Trial Outcomes & Findings for Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications (NCT NCT02627742)

Last Updated: 2024-01-29

Results Overview

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) * Patient requires prolonged mechanical ventilation (\> 24 hours from post-surgical admission) * Patient requires prolonged respiratory support for \> 24 hours from post-surgical admission * Diagnosis of pneumonia within seven (7) days * Readmission to ICU for pulmonary complications within seven (7) days of post-surgical hospital admission

Recruitment status

COMPLETED

Study phase

Target enrollment

419 participants

Primary outcome timeframe

Within seven (7) days of the post-surgical admission

Results posted on

2024-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	210	209
Overall Study COMPLETED	201	202
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.	Total n=419 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	129 Participants n=5 Participants	113 Participants n=7 Participants	242 Participants n=5 Participants
Age, Categorical >=65 years	81 Participants n=5 Participants	96 Participants n=7 Participants	177 Participants n=5 Participants
Age, Continuous	57.4 Years STANDARD_DEVIATION 15.48 • n=5 Participants	61.1 Years STANDARD_DEVIATION 13.72 • n=7 Participants	59.24 Years STANDARD_DEVIATION 14.73 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	78 Participants n=7 Participants	173 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	131 Participants n=7 Participants	246 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	203 Participants n=5 Participants	201 Participants n=7 Participants	404 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants	177 Participants n=7 Participants	345 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within seven (7) days of the post-surgical admission

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Significant Postoperative Pulmonary Complication Incidence. Number of subjects with ≥ 1 PPC	48 Participants	33 Participants
Significant Postoperative Pulmonary Complication Incidence. Number of subjects without ≥ 1 PPC	162 Participants	176 Participants

SECONDARY outcome

Timeframe: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical 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.

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Requirement for Invasive Mechanical Ventilation for > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission	19 Participants	14 Participants

SECONDARY outcome

Timeframe: 7 days (From the time of post-surgical admission to the hospital through day 7 following the initial post-surgical admission)

Respiratory support greater than the patient's baseline level for a period longer than 48 hours * Requirement for non-invasive ventilation (NIV) above patient's baseline requirement after hour 48 from post-surgical admission or continuous positive airway pressure (CPAP) above patient's baseline requirement after hour 48. * Requirement for O2 therapy \> 40 % FiO2 or \> 5 LPM pm via Nasal Cannula (and above patient's baseline) after hour 48 postoperatively.

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Requirement for Respiratory Support > 48 Hours Within Seven (7) Days of the Post-surgical Hospital Admission	21 Participants	19 Participants

SECONDARY outcome

Timeframe: Total days/hours until time of discharge from the hospital, up to 8 weeks

ICU length of stay, during initial hospital stay, was determined by calculating the number of days/hours spent in ICU. The following was documented: * Time of admission to the ICU to actual time of initial discharge from the ICU during initial hospital stay * Total ICU days/hours (includes readmissions) during initial hospital stay

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Length of ICU Stay During Initial Hospital Stay	2.11 Days Standard Deviation 6.004	1.27 Days Standard Deviation 2.672

SECONDARY outcome

Timeframe: Time of admission until time of discharge from the hospital, up to 8 weeks

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)

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Length of Hospital Stay During Initial Hospital Stay	8.40 Days Standard Deviation 7.895	6.78 Days Standard Deviation 4.978

SECONDARY outcome

Timeframe: during hospital stay, up to 8 weeks

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: * Number of readmission to ICU or elevated level of care events * Number of patients requiring readmission to the ICU or to an elevated level of care

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay Number of readmissions: None	205 Participants	204 Participants
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay Number of readmissions: Once	5 Participants	4 Participants
Readmission to ICU and Transfers to Elevated Level of Care for Pulmonary Complications During Initial Hospital Stay Number of readmissions: More than Once	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days following discharge from the 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.

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Readmission to Hospital	36 Participants	28 Participants

SECONDARY outcome

Timeframe: 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

* Time to initial extubation from time of initial intubation, if initial intubation was placed after surgery; or from time of post-surgical admission, if intubation was in place prior to start of surgery * Total time on invasive mechanical ventilation - was determined for each patient by calculating the total number of days/hours intubated and mechanically ventilated from the time of post-surgical admission until the time of initial hospital discharge. * Total time on non-invasive ventilation - was determined for each patient by calculating the total number of days/hours ordered for non-invasive ventilation from the time of post-surgical admission to the hospital unit until the time of initial hospital discharge.

Outcome measures

Outcome measures
Measure	Standard Therapy - Stage I n=210 Participants 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.	Change in Practice - Stage II n=209 Participants 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.
Time on Mechanical Ventilation Time to Initial Extubation	18.57 Hours Standard Deviation 75.04	7.64 Hours Standard Deviation 25.02
Time on Mechanical Ventilation Total Time on Invasive Mechanical Ventilation	23.7 Hours Standard Deviation 107.47	8.5 Hours Standard Deviation 27.40
Time on Mechanical Ventilation Total Time on Non-Invasive Mechanical Ventilation	0.5 Hours Standard Deviation 4.21	0.6 Hours Standard Deviation 3.31

Adverse Events

Standard Therapy - Stage I

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Change in Practice - Stage II

Serious events: 8 serious events

Other events: 1 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Standard Therapy - Stage I n=210 participants at risk 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.	Change in Practice - Stage II n=209 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Complications from pancreatic cancer	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
General disorders Intra-abdominal infection from untreated DLBCL	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Gastrointestinal disorders Pneumatosis intestinalis	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Cardiac disorders Cardiomyopathy; cardiac arrest	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Vascular disorders Inflammatory response syndrome due to aortic aneurysm	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Cardiac disorders Cardiorespiratory failure	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Nervous system disorders Hemorrhage- intracranial NOS, hemorrhage	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
General disorders Respiratory arrest, hepatic failure	0.48% 1/210 • Screening up to 8 weeks post-surgery	0.00% 0/209 • Screening up to 8 weeks post-surgery
Respiratory, thoracic and mediastinal disorders ARDS	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
Nervous system disorders Diffuse anoxic brain injury	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
Cardiac disorders Cardiac arrest, cause unspecified	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
General disorders Cardiac death	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
General disorders Cause of death is unknown	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
Cardiac disorders Cardiac Arrest	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery
Infections and infestations Pneumonia	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery

Other adverse events

Other adverse events
Measure	Standard Therapy - Stage I n=210 participants at risk 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.	Change in Practice - Stage II n=209 participants at risk 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.
General disorders Intolerant to device with agitation, increased work of breathing	0.00% 0/210 • Screening up to 8 weeks post-surgery	0.48% 1/209 • Screening up to 8 weeks post-surgery

Additional Information

Baxter Clinical Trials Disclosure Call Center

Baxter Healthcare

Phone: (224) 948-7359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place