Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine if a therapy regimen including treatment with The MetaNeb® System had a positive impact on the rate of pulmonary complications related to atelectasis and/or secretion retention that occur in high risk post-operative patients. This is a non-randomized facility (or hospital) level pre-post intervention study.
Post-operative pulmonary complications (PPC) are associated with significant excess morbidity, mortality and healthcare expenditure. Although PPCs are an incompletely understood multifactorial syndrome, atelectasis is recognized as a critical component. A variety of strategies have been shown to reduce the risk for development of post-operative atelectasis including lung expansion (LE) therapies. Well-designed studies are needed to distinguish which LE approach has the greatest potential to optimize patient care, clinical outcomes and cost savings.
Intrapulmonary percussive ventilation (IPV) devices have been in use for more than 25 years and are used widely in the acute care, post-surgical, and homecare setting. Such devices provide both LE and airway clearance therapy (ACT) for patients with obstructive and/or restrictive lung diseases and conditions. The MetaNeb® System is an LE expansion modality that incorporates all the physiological effects of IPV while providing additional therapeutic advantages intended primarily to more effectively treat or prevent pulmonary atelectasis.
The study was be conducted in two stages. In Stage I of the study, a retrospective review of medical records for post-surgical patients, who received STANDARD THERAPY as defined by current hospital and respiratory care department policies and procedures was performed. In Stage II, a CHANGE IN PRACTICE was made and patients received standard care with the addition of therapy with The MetaNeb® System. Demographic, clinical & outcome data was collected for eligible patients during the two stages of the study. Study staff collected data from the medical records, following a protocol determined schedule.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| METANEB | Experimental | Patients will receive standard care with the addition of therapy with The MetaNeb® System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetaNeb® System | Device | The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Significant Postoperative Pulmonary Complication Incidence. | One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC)
| Within seven (7) days of the post-surgical admission |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | Defined as patient requirement for invasive mechanical ventilation (MV) for > 48 hours (after hour 48) post-operatively. This includes patients that require re-intubation after hour 48, regardless of length of time on MV in the first 48 hours postoperatively. | 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) |
Not provided
Inclusion Criteria:
Age ≥ 18 years Post-thoracic, -upper abdominal or -aortic surgery Open surgical procedure Incision at or above the umbilicus
High risk defined by:
Documented ASA class ≥ 3 OR
Documented ASA class 2 AND One or more of the following:
Current smoker or smoking history within past 6 months History of COPD Documented obesity and/or BMI ≥ 30 kg/m2 Age ≥ 75
Exclusion Criteria:
Contraindication to Continuous High Frequency Oscillation (CHFO) therapy
Minimally invasive, or ". . . scopic" procedure.
Spinal surgery involving a posterior approach.
Surgery for organ transplant.
Chronic invasive positive pressure ventilation (PPV)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy Liesching, MD, FCCP | Lahey Hospital & Medical Center | Principal Investigator |
| Maurizio Cereda, MD | University of Pennsylvania | Principal Investigator |
| Toan Huynh, MD FACS FCCM | Carolinas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States | ||
| Carolinas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Huynh TT. et al., | ||
| 31362061 | Derived | Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Therapy - Stage I | Retrospectively collected medical records related to respiratory care from patients on STANDARD THERAPY without MetaNeb® as defined by current hospital and Respiratory Care department policies and procedures, was conducted. The purpose of Stage I was to estimate the incidence of postoperative pulmonary complications that occur in postsurgical patients who received standard therapy. |
| FG001 | Change in Practice - Stage II | Patients who received standard care with the addition of therapy with The MetaNeb® System. MetaNeb® System: The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study was that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patient's respiratory care regimen remained the same as during the standard therapy period, however the CHANGE IN PRACTICE incorporated the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System followed the labeling of the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Therapy - Stage I | Retrospectively collected medical records related to respiratory care from patients on STANDARD THERAPY without MetaNeb® as defined by current hospital and Respiratory Care department policies and procedures, was conducted. The purpose of Stage I was to estimate the incidence of postoperative pulmonary complications that occur in postsurgical patients who received standard therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Significant Postoperative Pulmonary Complication Incidence. | One or more of the following that occurs within seven (7) days of the post-surgical admission will be considered a Significant Postoperative Pulmonary Complication (PPC)
| Posted | Count of Participants | Participants | Within seven (7) days of the post-surgical admission |
|
Screening up to 8 weeks post-surgery
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Therapy - Stage I | Retrospectively collected medical records related to respiratory care from patients on STANDARD THERAPY without MetaNeb® as defined by current hospital and Respiratory Care department policies and procedures, was conducted. The purpose of Stage I was to estimate the incidence of postoperative pulmonary complications that occur in postsurgical patients who received standard therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications from pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerant to device with agitation, increased work of breathing | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baxter Clinical Trials Disclosure Call Center | Baxter Healthcare | (224) 948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2016 | Dec 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2016 | Jan 9, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | Respiratory support greater than the patient's baseline level for a period longer than 48 hours
| 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) |
| Length of ICU Stay During Initial Hospital Stay | ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented:
| Total days/hours until time of discharge from the hospital, up to 8 weeks |
| Length of Hospital Stay During Initial Hospital Stay | Hospital length of stay was determined by calculating the number of days/hours spent in hospital. The following was documented: • Time of admission to time of discharge from the hospital (total days/hours) | Time of admission until time of discharge from the hospital, up to 8 weeks |
| Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Readmissions to ICU and transfers to an elevated level of care, during the initial hospital stay, was documented for each event. The following was documented:
| during hospital stay, up to 8 weeks |
| Readmission to Hospital | Hospital records were reviewed at each site, 30 days after the last patient has been discharged from the hospital. Readmissions, for any cause, within 30 days of discharge for any study patient were documented. | 30 days following discharge from the hospital |
| Time on Mechanical Ventilation |
| total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks |
| Charlotte |
| North Carolina |
| 28203 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | Change in Practice - Stage II | Patients who received standard care with the addition of therapy with The MetaNeb® System. MetaNeb® System: The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study was that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patient's respiratory care regimen remained the same as during the standard therapy period, however the CHANGE IN PRACTICE incorporated the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System followed the labeling of the device. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Change in Practice - Stage II | Patients who received standard care with the addition of therapy with The MetaNeb® System. MetaNeb® System: The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study was that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patient's respiratory care regimen remained the same as during the standard therapy period, however the CHANGE IN PRACTICE incorporated the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System followed the labeling of the device. |
|
|
| Secondary | Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | Defined as patient requirement for invasive mechanical ventilation (MV) for > 48 hours (after hour 48) post-operatively. This includes patients that require re-intubation after hour 48, regardless of length of time on MV in the first 48 hours postoperatively. | Posted | Count of Participants | Participants | 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) |
|
|
|
| Secondary | Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission | Respiratory support greater than the patient's baseline level for a period longer than 48 hours
| Posted | Count of Participants | Participants | 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission) |
|
|
|
| Secondary | Length of ICU Stay During Initial Hospital Stay | ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented:
| Posted | Mean | Standard Deviation | Days | Total days/hours until time of discharge from the hospital, up to 8 weeks |
|
|
|
| Secondary | Length of Hospital Stay During Initial Hospital Stay | Hospital length of stay was determined by calculating the number of days/hours spent in hospital. The following was documented: • Time of admission to time of discharge from the hospital (total days/hours) | Posted | Mean | Standard Deviation | Days | Time of admission until time of discharge from the hospital, up to 8 weeks |
|
|
|
| Secondary | Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay | Readmissions to ICU and transfers to an elevated level of care, during the initial hospital stay, was documented for each event. The following was documented:
| Posted | Count of Participants | Participants | during hospital stay, up to 8 weeks |
|
|
|
| Secondary | Readmission to Hospital | Hospital records were reviewed at each site, 30 days after the last patient has been discharged from the hospital. Readmissions, for any cause, within 30 days of discharge for any study patient were documented. | Posted | Count of Participants | Participants | 30 days following discharge from the hospital |
|
|
|
| Secondary | Time on Mechanical Ventilation |
| Posted | Mean | Standard Deviation | Hours | total hours/days from the time of the post-surgical admission to the hospital unit until time of discharge from the hospital, up to 8 weeks |
|
|
|
| 9 |
| 210 |
| 9 |
| 210 |
| 0 |
| 210 |
| EG001 | Change in Practice - Stage II | Patients who received standard care with the addition of therapy with The MetaNeb® System. MetaNeb® System: The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study was that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patient's respiratory care regimen remained the same as during the standard therapy period, however the CHANGE IN PRACTICE incorporated the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System followed the labeling of the device. | 7 | 209 | 8 | 209 | 1 | 209 |
| Intra-abdominal infection from untreated DLBCL | General disorders | Non-systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cardiomyopathy; cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Inflammatory response syndrome due to aortic aneurysm | Vascular disorders | Non-systematic Assessment |
|
| Cardiorespiratory failure | Cardiac disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hemorrhage- intracranial NOS, hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Respiratory arrest, hepatic failure | General disorders | Non-systematic Assessment |
|
| ARDS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diffuse anoxic brain injury | Nervous system disorders | Non-systematic Assessment |
|
| Cardiac arrest, cause unspecified | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac death | General disorders | Non-systematic Assessment |
|
| Cause of death is unknown | General disorders | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
| Number of readmissions: More than Once |
|
| Total Time on Non-Invasive Mechanical Ventilation |
|