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To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.
Study Population:
Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results.
Duration of treatment:
Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The MetaNeb® System Treatment | Other | Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MetaNeb® System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) | Approximately 48 hours post-initiation of therapy with The MetaNeb® System. |
| Measure | Description | Time Frame |
|---|---|---|
| Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Mean chest x-ray score change for both lungs at Day 1 (approx. 24 hours) and at Day 4 (approx. 96 hours or at discharge, if discharge occurs before Day 4) after initiation of therapy with The MetaNeb® System. Scored using the Kelly score, as described above, to assess the presence of atelectasis. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Diamant, M.D., F.C.C.P | Hoag Memorial Hospital, Newport Beach, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92658 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | The MetaNeb® System Treatment | Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. The MetaNeb® System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The MetaNeb® System Treatment | Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. The MetaNeb® System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. | Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) | Posted | Mean | Standard Deviation | scores on a scale | Approximately 48 hours post-initiation of therapy with The MetaNeb® System. |
|
4 Days
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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 | The MetaNeb® System Treatment | Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. The MetaNeb® System |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baxter Clinical Trials Disclosure Call Center | Baxter Healthcare | (224) 948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2017 | Jul 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4 |
| Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Chest x-ray improvement using a comparative scale after a minimum of forty-eight (48) hours of therapy with The MetaNeb® System. Chest x-ray improvement assessed using comparative scale for baseline, Day 1, Day 2, and Day 4/discharge. Four chest x-rays for each enrolled subject (baseline, Day 1, Day 2, and day 4/discharge), with date and time masked, were sent to the radiologist for comparison. The radiologist ranked the four x-rays as 1, 2, 3, or 4 (1 = least atelectasis, 4 = most atelectasis). *Subjects 3 and 4 were discharged on Day 2, and therefore the Day 2 and Day 4/Early Discharge Chest X-rays are one in the same for the purposes of the analysis | Comparing baseline, Day 1, Day 2, and Day 4/discharge. |
| Oxygenation Index (SpO2 /FiO2 Ratio). | Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline. SPO2/FiO2 is available for only the 6 subjects that received oxygen during the study. Subjects 3 and 4 did not receive oxygen and no SPO2/FiO2 ratios were calculated. higher SPO2/FiO2 value indicates better oxygenation. | Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge |
| Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Patient reported level of dyspnea (assessed by Modified Borg Dyspnea Scale).This is a scale that asks patients to rate the difficulty of their breathing. It starts at number zero (0) where the breathing is causing the patient no difficulty at all, and progresses through to number ten (10) where the patients' breathing difficulty is maximal. 0: Nothing at all; 0.5: Very, very slight (just noticeable); 1: Very slight; 2: Slight; 3: Moderate; 4: Somewhat severe; 5: Severe; 7: Very severe; 9: Very, very severe (almost maximal); 10: Maximal. | Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2. |
| Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Change in patient respiratory status (Respiratory Status Evaluation). Physician observation and evaluation of patient respiratory status at time of enrollment (baseline) and on Day 2 to assess if worse, unchanged, or improved through:
| Respiratory status evaluation at time of enrollment and on Day 2 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| History of Asthma | Count of Participants | Participants |
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| COPD | Count of Participants | Participants |
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| Obstructive Sleep Apnea | Count of Participants | Participants |
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| Other Pulmonary Condition | Count of Participants | Participants |
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| Bronchiectasis | Count of Participants | Participants |
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| Neuromuscular disease | Count of Participants | Participants |
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| Cystic Fibrosis | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | The MetaNeb® System Treatment | Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. The MetaNeb® System |
|
|
| Secondary | Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline. | Mean chest x-ray score change for both lungs at Day 1 (approx. 24 hours) and at Day 4 (approx. 96 hours or at discharge, if discharge occurs before Day 4) after initiation of therapy with The MetaNeb® System. Scored using the Kelly score, as described above, to assess the presence of atelectasis. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,) | Posted | Mean | Standard Deviation | scores on a scale | Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4 |
|
|
|
| Secondary | Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge). | Chest x-ray improvement using a comparative scale after a minimum of forty-eight (48) hours of therapy with The MetaNeb® System. Chest x-ray improvement assessed using comparative scale for baseline, Day 1, Day 2, and Day 4/discharge. Four chest x-rays for each enrolled subject (baseline, Day 1, Day 2, and day 4/discharge), with date and time masked, were sent to the radiologist for comparison. The radiologist ranked the four x-rays as 1, 2, 3, or 4 (1 = least atelectasis, 4 = most atelectasis). *Subjects 3 and 4 were discharged on Day 2, and therefore the Day 2 and Day 4/Early Discharge Chest X-rays are one in the same for the purposes of the analysis | Posted | Number | scores on a scale | Comparing baseline, Day 1, Day 2, and Day 4/discharge. |
|
|
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| Secondary | Oxygenation Index (SpO2 /FiO2 Ratio). | Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline. SPO2/FiO2 is available for only the 6 subjects that received oxygen during the study. Subjects 3 and 4 did not receive oxygen and no SPO2/FiO2 ratios were calculated. higher SPO2/FiO2 value indicates better oxygenation. | Posted | Number | SPO2/FiO2 ratio | Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge |
|
|
|
| Secondary | Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale. | Patient reported level of dyspnea (assessed by Modified Borg Dyspnea Scale).This is a scale that asks patients to rate the difficulty of their breathing. It starts at number zero (0) where the breathing is causing the patient no difficulty at all, and progresses through to number ten (10) where the patients' breathing difficulty is maximal. 0: Nothing at all; 0.5: Very, very slight (just noticeable); 1: Very slight; 2: Slight; 3: Moderate; 4: Somewhat severe; 5: Severe; 7: Very severe; 9: Very, very severe (almost maximal); 10: Maximal. | Posted | Mean | Standard Deviation | scores on a scale | Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2. |
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| Secondary | Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation. | Change in patient respiratory status (Respiratory Status Evaluation). Physician observation and evaluation of patient respiratory status at time of enrollment (baseline) and on Day 2 to assess if worse, unchanged, or improved through:
| Posted | Count of Participants | Participants | Respiratory status evaluation at time of enrollment and on Day 2 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| Title | Measurements |
|---|---|
|
| Subject 4: Baseline Score |
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| Subject 4: Day 1 Score |
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| Subject 4: Day 4/Early Termination Score |
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| Subject 5: Baseline Score |
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| Subject 5: Day 1 Score |
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| Subject 5: Day 4/Early Termination Score |
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| Subject 6: Baseline Score |
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| Subject 6: Day 1 Score |
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| Subject 6: Day 4/Early Termination Score |
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| Subject 8: Baseline Score |
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| Subject 8: Day 1 Score |
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| Subject 8: Day 4/Early Termination Score |
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| Title | Measurements |
|---|---|
|
| Subject 1 - Day 4/Early Discharge |
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| Subject 2 - Baseline |
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| Subject 2 - Day 1 |
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| Subject 2 - Day 2 |
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| Subject 2 - Day 4/Early Discharge |
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| Subject 3 - Baseline |
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| Subject 3 - Day 1 |
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| Subject 3 - Day 2* |
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| Subject 3 - Day 4/Early Discharge* |
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| Subject 4 - Baseline |
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| Subject 4 - Day 1 |
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| Subject 4 - Day 2* |
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| Subject 4 - Day 4/Early Discharge* |
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| Subject 5 - Baseline |
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| Subject 5 - Day 1 |
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| Subject 5 - Day 2 |
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| Subject 5 - Day 4/Early Discharge |
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| Subject 6 - Baseline |
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| Subject 6 - Day 1 |
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| Subject 6 - Day 2 |
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| Subject 6 - Day 4/Early Discharge |
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| Subject 7 - Baseline |
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| Subject 7 - Day 1 |
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| Subject 7 - Day 2 |
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| Subject 7 - Day 4/Early Discharge |
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| Subject 8 - Baseline |
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| Subject 8 - Day 1 |
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| Subject 8 - Day 2 |
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| Subject 8 - Day 4/Early Discharge |
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| Title | Measurements |
|---|---|
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| Subject 1 - Day 2 AM |
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| Subject 1 - Day 2 PM |
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| Subject 1 - Day 4/Early Discharge |
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| Subject 2 - Baseline |
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| Subject 2 - Day 1 AM |
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| Subject 2 - Day 1 PM |
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| Subject 2 - Day 2 AM |
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| Subject 2 - Day 2 PM |
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| Subject 2 - Day 4/Early Discharge |
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| Subject 5 - Baseline |
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| Subject 5 - Day 1 AM |
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| Subject 5 - Day 1 PM |
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| Subject 5 - Day 2 AM |
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| Subject 5 - Day 2 PM |
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| Subject 5 - Day 4/Early Discharge |
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| Subject 6 - Baseline |
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| Subject 6 - Day 1 AM |
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| Subject 6 - Day 1 PM |
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| Subject 6 - Day 2 AM |
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| Subject 6 - Day 2 PM |
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| Subject 6 - Day 4/Early Discharge |
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| Subject 7 - Baseline |
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| Subject 7 - Day 1 AM |
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| Subject 7 - Day 1 PM |
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| Subject 7 - Day 2 AM |
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| Subject 7 - Day 2 PM |
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| Subject 7 - Day 4/Early Discharge |
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| Subject 8 - Baseline |
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| Subject 8 - Day 1 AM |
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| Subject 8 - Day 1 PM |
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| Subject 8 - Day 2 AM |
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| Subject 8 - Day 2 PM |
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| Subject 8 - Day 4/Early Discharge |
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| Title | Measurements |
|---|---|
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| Lung Assessment: Auscultation |
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| Cough Assessment |
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| Secretion Assessment |
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| Oxygenation |
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| Work of Breathing |
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| Other Observations (General Appearance, Mental Acuity, Respiratory Pain) |
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