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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS045087 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purposes of the study are to determine the energy balance and evaluate the nutritional status of patients with ALS, and to investigate the use of NIPPV as respiratory support to treat patients with ALS.
Studies to date indicate that percutaneous endoscopic gastrostomy (PEG)-insertion of a feeding tube in the stomach-and non-invasive positive pressure ventilation (NIPPV)-mechanically assisted or generated breaths delivered through a tightly fitting nasal or facial mask-improve survival in amyotrophic lateral sclerosis (ALS), even when introduced late in the disease.
Dr. Kasarskis and his research team believe early intervention with these treatments may improve patients outcome even further. However, many issues regarding the early use of these treatments prevent the design of a phase III clinical trial to test this hypothesis. Common to both NIPPV and nutrition is a lack of a reliable indicator of early respiratory or nutritional insufficiency. With respect to nutrition, reliable and cost effective methods are needed to determine a patient's energy (i.e. caloric) requirements at different stages of the illness to establish a basis for recommending PEG on the adequacy of energy intake. For NIPPV, factors that influence acceptance and tolerability of this therapy, and measurements of early respiratory dysfunction need to be identified.
The purposes of this trial are to develop and validate strategies to improve tolerability of NIPPV, identify factors that influence acceptance of NIPPV, and evaluate measures of early respiratory failure, other than percentage of forced vital capacity (FVC). Researchers will also develop and validate methods to determine energy balance in and evaluate the nutritional status of patients with ALS that will be applicable to a multi-center phase III study of nutrition and NIPPV.
The study will be conducted at 11 other sites across the country. Some study sites will focus on the nutritional aspects of the trial while the other sites will focus on NIPPV treatment. A total of 220 patients will be studied over 2 years.
Enrollment will end on June 30, 2007. The last patient was followed clinically until June 30, 2008. The study remained open for sample analysis, data analysis, and assessment of vital status until the completion of funding on November 30, 2009.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early NIPPV Intervention | Experimental | Participants with >80% predicted forced vital capacity (FVC). |
|
| Standard of Care NIPPV | Active Comparator | Participants with 50-74% predicted forced vital capacity (FVC). |
|
| Standard of Care NIPPV and Nutritional Monitoring | Active Comparator | Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early NIPPV | Device | Early intervention with non-invasive positive pressure ventilation (NIPPV) at 80% forced vital capacity (FVC). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment. | Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer. | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival With Early Versus Standard of Care NIPPV Treatment | Duration of patient survival | one year |
| Compliance With NIPPV Treatment | Number of hours of NIPPV use per month |
Inclusion Criteria:
FVC Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Kasarskis, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80262 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24522445 | Background | Kasarskis EJ, Mendiondo MS, Matthews DE, Mitsumoto H, Tandan R, Simmons Z, Bromberg MB, Kryscio RJ; ALS Nutrition/NIPPV Study Group. Estimating daily energy expenditure in individuals with amyotrophic lateral sclerosis. Am J Clin Nutr. 2014 Apr;99(4):792-803. doi: 10.3945/ajcn.113.069997. Epub 2014 Feb 12. | |
| 29243507 | Background | Scagnelli CN, Howard DB, Bromberg MB, Kasarskis EJ, Matthews DE, Mitsumoto HM, Simmons Z, Tandan R; ALS Nutrition-NIPPV Study Group. Hydration measured by doubly labeled water in ALS and its effects on survival. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):220-231. doi: 10.1080/21678421.2017.1413117. Epub 2017 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care NIPPV and Nutritional Monitoring | Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard NIPPV | Device | Standard of care non-invasive positive pressure ventilation (NIPPV) at 50% forced vital capacity (FVC). |
|
|
| one month |
| Total Daily Energy Expediture (TDEE) of ALS Patients | Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method | Duration of study (approximately 1 year) |
| Tolerance of NIPPV Treatment | Percent of patients achieving tolerance (>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data. | one month |
| Miami |
| Florida |
| 33136 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Beth Israel | New York | New York | 10003 | United States |
| Columbia University | New York | New York | 10032 | United States |
| SUNY | Syracuse | New York | 13210 | United States |
| Pennsylvania State University | Hershey | Pennsylvania | 17033 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19103 | United States |
| University of Texas-San Antonio | San Antonio | Texas | 78229 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Vermont | Burlington | Vermont | 54505 | United States |
| 21271789 | Result | Kasarskis EJ, Mendiondo MS, Wells S, Malguizo MS, Thompson M, Healey M, Kryscio RJ; ALS Nutrition/NIPPV Study Group. The ALS Nutrition/NIPPV Study: design, feasibility, and initial results. Amyotroph Lateral Scler. 2011 Jan;12(1):17-25. doi: 10.3109/17482968.2010.515225. |
| Standard of Care NIPPV |
Participants with 50-74% predicted forced vital capacity (FVC). |
| FG002 | Early NIPPV | Participants with >80% predicted forced vital capacity (FVC). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care NIPPV and Nutritional Monitoring | Participants with 50-95% forced vital capacity (FVC), and normal or impaired amyotrophic lateral sclerosis functional rating scale (ALSFRS) scores. Participants in this group will receive standard of care NIPPV therapy but will also undergo detailed analysis of nutritional status. |
| BG001 | Standard of Care NIPPV | Participants with 50-74% predicted forced vital capacity (FVC). |
| BG002 | Early NIPPV Intervention | Participants with >80% predicted forced vital capacity (FVC). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptance Rate of Early Non-invasive Positive Pressure Ventilation (NIPPV) Treatment. | Percentage of patients attempting to use NIPPV therapy within six weeks of initial offer. | Data were not obtained from the "Standard of Care NIPPV and Nutritional Monitoring" arm. | Posted | Count of Participants | Participants | 6 weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Patient Survival With Early Versus Standard of Care NIPPV Treatment | Duration of patient survival | Not Posted | one year | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Compliance With NIPPV Treatment | Number of hours of NIPPV use per month | Not Posted | one month | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Total Daily Energy Expediture (TDEE) of ALS Patients | Total daily energy expenditure (TDEE) with be measured using the dual labeled water (DLW) method | Not Posted | Duration of study (approximately 1 year) | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tolerance of NIPPV Treatment | Percent of patients achieving tolerance (>4hr/night NIPPV after 2-3 week titration period) determined by actual usage data. | No data were collected for the "Standard of Care NIIPPV and Nutritional Monitoring" arm. | Posted | Count of Participants | Participants | one month |
|
|
3 years, 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Arms | Sincere efforts were made to locate per arm data, but these data are no longer available. All adverse events are reported as one arm/group. | 19 | 153 | 42 | 153 | 62 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALS Progression | Nervous system disorders | Systematic Assessment | Dates: 5/5/2007 5/25/2007 Status: Resolved Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Moderate Relationship to study: Unrelated Description: Treatment and Evaluation of ALS Progression |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 5/11/2008 5/12/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: Aspiration |
| |
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 6/10/2007 6/19/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Presumed Aspiration Pneumonia |
| |
| Bladder malignancy/UTI | Renal and urinary disorders | Systematic Assessment | Dates: 8/22/2007 9/5/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Possible bladder malignancy and UTI |
| |
| Blood Clot | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 8/21/2005 9/1/2005 Status:Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Blood Clot Behind right knee |
| |
| Cardiac Arrest | Cardiac disorders | Systematic Assessment | Dates: 4/4/2006 4/4/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: Cardiac Arrest |
| |
| Colonic Bleed | Gastrointestinal disorders | Systematic Assessment | Dates: 1/15/2007 1/29/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship: Unrelated Description: Left Colonic Bleed |
| |
| Concussion | Nervous system disorders | Systematic Assessment | Dates: 2/7/2007 2/7/2007 Status: Resolved Reason for Qualifying: Life-threatening Intensity: Moderate Relationship to Study: Unrelated Description: Concussion as result of Automobile Accident |
| |
| Death | General disorders | Systematic Assessment | Dates: 6/2/2006 6/2/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to Study: Unrelated Description: No Information Given |
| |
| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 5/21/2007 5/27/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Difficulty breathing due to Sialorrhea |
| |
| Dislodged PEG Tube | Gastrointestinal disorders | Systematic Assessment | Dates: 6/30/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Dislodged PEG Tube and Respiratory Distress |
| |
| Distended Abdomen | Gastrointestinal disorders | Systematic Assessment | Dates: 8/24/2005 8/29/2005 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Distended Abdomen |
| |
| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Dates: 3/11/2008 3/11/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Dysphagia |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 4/9/2007 Status: Continuing at discontinuation Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Increased Dyspnea |
| |
| Failure to Thrive | Metabolism and nutrition disorders | Systematic Assessment | Dates: 7/23/2007 8/10/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to Study: Unrelated Description: Diagnosed as failure to thrive |
| |
| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 4/25/2006 5/4/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Left Hip Fracture Resulting From Fall |
| |
| Hypokalemia, hypomagnesia, and antythmia | Metabolism and nutrition disorders | Systematic Assessment | Dates: 12/15/2007 12/17/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Hypokalemia, hypomagnesia, and antythmia |
| |
| Infection | Infections and infestations | Systematic Assessment | Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Severe infection |
| |
| Irregular Heartbeat | Cardiac disorders | Systematic Assessment | Dates: 1/18/2008 2/17/2008 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Irregular Heartbeat |
| |
| Laceration | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 9/9/2007 11/4/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Debridement and Closure of Laceration |
| |
| Liver Cancer Diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Dates: 11/4/2005 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship to Study: Unrelated Description: Liver Cancer Diagnosis |
| |
| Loculated right pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 7/27/2007 8/2/2007 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Loculated right pleural effusion and possible Pneumonia |
| |
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | Dates: 8/30/2007 8/31/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Apparent Myocardial Infarction |
| |
| PEG Procedure Complications | Gastrointestinal disorders | Systematic Assessment | Dates: 5/11/2006 5/12/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Moderate Relationship to study: Unrelated Description: Complications from PEG Procedure |
| |
| Peg Replacement | Surgical and medical procedures | Systematic Assessment | Dates: 3/14/2008 3/18/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Mild Relationship to study: Unrelated Description: PEG replacement |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 3/6/2008 3/19/2008 Status: Resolved Reason for qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pneumonia |
| |
| Pulmonary Emboli and pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 9/3/2006 10/5/2006 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to study: Unrelated Description: Pulmonary emboli and pneumonia |
| |
| Respiratory Complications | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 10/7/2006 10/7/2006 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description: Respiratory Complications |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 9/28/2007 9/28/2007 Status: Resolved Reason for qualifying: Requiring or prolonging Hospitalization Intensity: Severe Relationship to study: Unrelated Description: continued respiratory decline |
| |
| Sepsis | Gastrointestinal disorders | Systematic Assessment | Dates: 10/3/2007 10/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Severe Sepsis around PEG Tube |
| |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 10/2/2006 Status: Continuing at discontinuation Reason for Qualifying: Are other conditions which represent significant hazards Intensity: Severe Relationship: Unrelated Description: Shortness of breath |
| |
| Subarachroid Hemmorrhage and Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 3/14/2007 3/16/2007 Status: Resolved Reason for Qualifying: Resulting in death Severe Relationship to Study: Unrelated Description: Sub-arachnoid Haemmorrhage and Contusion Resulting from fall |
| |
| Subdural Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 6/11/2007 6/11/2007 Status: Resolved Reason for Qualifying: Requiring or prolonging hospitalization Intensity: Severe Relationship to Study: Unrelated Description: Subdural Hematoma from fall |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Dates: 9/6/2007 9/23/2007 Status: Resolved Reason for Qualifying: Resulting in death Intensity: Severe Relationship to study: Unrelated Description Small bowel obstruction, transitional cell carcinoma |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment | Dates: 3/20/2007 Status: Unresolved at 48 Weeks Description: Abdominal distension Intensity: moderate Relationship to study: possible |
| |
| Abnormal Lab | Metabolism and nutrition disorders | Systematic Assessment | Dates: 5/2/2006 8/21/2006 Status: Resolved Description: Abnormal Lab Intensity: mild Relationship to study: not related |
| |
| Allergy | Immune system disorders | Systematic Assessment | Dates: 4/17/2007 4/22/2007 Status: Ended Description: Allergy Intensity: mild Relationship to study: not related |
| |
| Ankle Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 9/6/2006 Status: Ended Description: Ankle Sprain Intensity: moderate Relationship to study: not related |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 3/27/2007 Status: Unresolved at 48 Weeks Description: Arthritis Intensity: mild Relationship to study: not related |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates:: 6/3/2006 Status: Unresolved at 48 weeks Description: Back Pain Intensity: moderate Relationship to study: not related |
| |
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 4/1/2008 Status: Unresolved at 48 Weeks Description: Blister Intensity: mild Relationship to study: not related |
| |
| Blood Clot | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 1/28/2008 Status: Unresolved at 48 Weeks Description: Blood Clot Intensity: moderate Relationship to study: not related |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 1/20/2008 2/10/2008 Status: Ended Description: Bronchitis Intensity: moderate Relationship to study: possible |
| |
| Bruise | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 5/11/2006 5/11/2006 Status:Ended Description: Bruise Intensity: mild Relationship to study: not related |
| |
| Burning Sensation | General disorders | Systematic Assessment | Dates: 7/23/2007 Status: Continuing Description: PAIN Burning Sensation Intensity: severe Relationship to study: not related |
| |
| Cold | General disorders | Systematic Assessment | Dates: 8/9/2007 8/15/2007 Status: Ended Description: Cold Intensity: mild Relationship to study: not related |
| |
| Colon Polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Dates: 2/1/2006 2/1/2006 Status: Ended Description: Colon Polyp Intensity: mild Relationship: not related |
| |
| Concussion | Nervous system disorders | Systematic Assessment | Dates: 2/6/2006 2/6/2006 Status: Ended Description: Concussion Intensity: severe Relationship to study: not related |
| |
| Congestion | Immune system disorders | Systematic Assessment | Dates: 7/21/2006 7/31/2006 Status: Resolved Description: Congestion Intensity: moderate Relationship to study: not related |
| |
| Conjunctivitis | Infections and infestations | Systematic Assessment | Dates: 7/3/2007 7/8/2007 Status: Ended Description: Conjunctivitis Intensity: mild Relationship to study: not related |
| |
| Constipation | Gastrointestinal disorders | Systematic Assessment | Dates: 2/1/2006 6/1/2006 Status: Resolved Description: Constipation Intensity: moderate Relationship to study: not likely |
| |
| Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 7/4/2007 7/4/2007 Status: Ended Description: Contusion Intensity: mild Relationship to study: not related |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 9/7/2006 Status: Ended Description: Cough Intensity: moderate Relationship: not related |
| |
| Decreased Rectal Tone | Gastrointestinal disorders | Systematic Assessment | Dates: 6/4/2007 Status: Continuing Description: Decreased Rectal Tone Intensity: moderate Relationship to study: not related |
| |
| Dehydration | Gastrointestinal disorders | Systematic Assessment | Dates: 3/5/2008 Description: Dehydration Intensity: mild Relationship to study: not likely |
| |
| Dental | Gastrointestinal disorders | Systematic Assessment | Dates: 4/17/2006 Status: Ended Description: Dental Intensity: moderate Relationship to study: not related |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 3/1/2008 Status: Unresolved at 48 Weeks Description: Dermatitis Intensity: mild Relationship to study: possible |
| |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Dates: 2/10/2007 2/10/2007 Status: Ended Description: Diarrhea Intensity: mild Relationship to study: not related |
| |
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment | Dates: 10/15/2006 11/14/2006 Status: Resolved Description: Diverticulitis Intensity: severe Relationship to study: not related |
| |
| Dizziness | Nervous system disorders | Systematic Assessment | Dates: 1/15/2006 Status: Ended Description: Dizziness Intensity: moderate Relationship to study: not related |
| |
| Dry Eye | Eye disorders | Systematic Assessment | Dates: 10/15/2007 Description:Dry Eye Intensity: mild Relationship to study: probable |
| |
| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Dates: 6/15/2006 Status: Unresolved at 48 Weeks Description: Dysphagia Intensity: mild Relationship to study: not likely |
| |
| Ear Infection | Infections and infestations | Systematic Assessment | Dates: 10/1/2006 10/26/2006 Status: Resolved Description: Ear Infection Intensity: mild Relationship to study: not related |
| |
| Edema | Blood and lymphatic system disorders | Systematic Assessment | Dates: 10/24/2006 Status: Unresolved at 48 Weeks Description: Edema Intensity: mild Relationship to study: not likely |
| |
| Fall | General disorders | Systematic Assessment | Dates: 4/13/2007 4/13/2007 Status: Ended Description: Fall Intensity: mild Relationship to study: not related |
| |
| Fatigue | General disorders | Systematic Assessment | Dates: 11/1/2005 Status: Unresolved at Discontinuation Description: Fatigue Intensity: severe Relationship to study: not related |
| |
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 1/18/2007 3/29/2007 Status: Resolved Description: Fracture Intensity: mild Relationship to study: not related |
| |
| Gastritis | Gastrointestinal disorders | Systematic Assessment | Dates: 9/25/2006 10/2/2006 Status: Ended Description: Gastritis Intensity: severe Relationship to study: not related |
| |
| Hallucination | Nervous system disorders | Systematic Assessment | Dates: 9/13/2006 9/16/2006 Status: Ended Description: Hallucination Intensity: moderate Relationship to study: not related |
| |
| Headache | Nervous system disorders | Systematic Assessment | Dates: 1/18/2006 3/1/2006 Status: Ended Description: Headache Intensity: mild Relationship to study: not related |
| |
| Hypercarbia | Metabolism and nutrition disorders | Systematic Assessment | Dates: 11/6/2006 Status: Continuing Description: Hypercarbia Intensity: mild Relationship to study: not related |
| |
| Hypertension | Cardiac disorders | Systematic Assessment | Dates: 1/11/2008 Status: Unresolved at 48 Weeks Description: Hypertension Intensity: mild Relationship to study: not likely |
| |
| Hypotension | Cardiac disorders | Systematic Assessment | Dates: 11/4/2006 11/4/2006 Status: Ended Description: Hypotension Intensity: mild Relationship to Study: not related |
| |
| Infection | Infections and infestations | Systematic Assessment | Dates: 10/26/2007 11/4/2007 Status: Ended Description: Infection Intensity: mild Relationship to study: not related |
| |
| Knee Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 6/30/2007 7/13/2007 Status: Ended Description: Knee Sprain Intensity: moderate Relationship to study: not related |
| |
| Laceration | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 2/5/2007 2/5/2007 Status: Ended Description: Laceration Intensity: mild Relationship to study: not related |
| |
| Lesion | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 3/30/2007 5/7/2007 Status: Ended Description: Lesion Intensity: mild Relationship to study: definite |
| |
| Nosebleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 11/1/2007 Status: Continuing Description: Nosebleed Intensity: mild Relationship to study: probable |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 9/4/2006 Status: Unresolved at 48 Weeks Description: Osteopenia Intensity: mild Relationship to study: not likely |
| |
| PEG | Gastrointestinal disorders | Systematic Assessment | Dates: 6/29/2006 7/1/2006 Status: Ended Description: PEG Intensity: moderate Relationship to study: not related |
| |
| Pain | General disorders | Systematic Assessment | Dates: 11/20/2006 12/18/2006 Status: Resolved Description: Pain Intensity: moderate Relationship to study: not related |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 11/1/2007 Status: Unresolved at 48 Weeks Description: Pneumonia Intensity: moderate Relationship to study: not related |
| |
| Post Nasal Drip | Immune system disorders | Systematic Assessment | Dates: 3/31/2006 Status: Unresolved at 48 Weeks Description: Post Nasal Drip Intensity: severe Relationship to study: not related |
| |
| Pressure Sores | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 11/28/2006 11/30/2006 Status: Resolved Description: Pressure Sores Intensity: mild Relationship to study: not related |
| |
| RADS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 1/17/2007 4/30/2007 Status: Ended Description: RADS Intensity: mild Relationship: not related |
| |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Dates: 8/15/2005 Status: Unresolved at 48 Weeks Description: Rash Intensity: mild Relationship to study: not likely |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 2/25/2007 2/25/2007 Status: Ended Description: Shortness of Breath Intensity: moderate Relationship to study: not related |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 1/23/2006 1/25/2006 Status: Ended Description: Shoulder Pain Intensity: severe Relationship to study: not related |
| |
| Sialorrhea | Gastrointestinal disorders | Systematic Assessment | Dates: 2/10/2006 Status: Unresolved at 48 Weeks Description: Sialorrhea Intensity: mild Relationship to study: not related |
| |
| Sinus Infection | Infections and infestations | Systematic Assessment | Dates: 4/1/2007 4/7/2007 Status: Ended Description: Sinus Infection Severity: moderate Relationship to study: not related |
| |
| Sore Throat | General disorders | Systematic Assessment | Dates: 10/12/2006 Status: Unresolved at 48 Weeks Description: Sore Throat Intensity: mild Relationship to study: not related |
| |
| Spasm (Respiratory) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 1/19/2007 1/19/2007 Status: Resolved Description: Spasm Intensity: mild Relationship to study: not related |
| |
| Stomach Upset | Gastrointestinal disorders | Systematic Assessment | Dates: 4/29/2006 5/1/2006 Status: Ended Description: Stomach Upset Intensity: mild Relationship to study: not related |
| |
| UTI | Infections and infestations | Systematic Assessment | Dates: 3/14/2006 3/24/2006 Status: Ended Description: UTI Intensity: moderate Relationship to study: not related |
| |
| Urgent Bowel Movements | Gastrointestinal disorders | Systematic Assessment | Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Urgent Bowel Movements Intensity: mild Relationship to study: possible |
| |
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment | Dates: 6/11/2007 6/24/2007 Status: Ended Description: Urinary Frequency Intensity: moderate Relationship to study: not likely |
| |
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Dates: 10/18/2005 10/18/2005 Status: Ended Description: Vomiting Intensity: mild Relationship to study: not related |
| |
| Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dates: 2/1/2006 Status: Unresolved at Discontinuation Description: Weakness Intensity: mild Relationship to study: not related |
| |
| Weight Loss | General disorders | Systematic Assessment | Dates: 8/8/2005 3/13/2006 Status: Ended Description: Weight Loss Intensity: moderate Relationship to study: not related |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dates: 11/6/2006 Status: Resolved Description: Wheezing Intensity: moderate Relationship to study: not related |
|
Compliance with NIPPV intervention is limited due to technical difficulties in obtaining BiPAP download data from some sites. This was due to variability in the local respiratory therapists engaged by commercial respiratory therapy companies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward J. Kasarskis, M.D., Ph.D. | University of Kentucky | 859-218-5061 | ejkas@uky.edu |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Male |
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| Participants |
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