Evaluation of The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Atelectasis Clinical Trial

Official title:

Evaluation of a Practice Change to Include The MetaNeb® System to Reduce Postoperative Pulmonary Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627742
• Other study ID #: CR-RR2015-001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2024
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis
• Pulmonary Complications

Intervention

Device:
• MetaNeb® System
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.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

References & Publications (1)

Huynh TT. et al.,

Outcome

Type	Measure	Description	Time frame	Safety issue
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); 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	Within seven (7) days of the post-surgical admission
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.	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; 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.	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: 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	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)	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: 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	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.	30 days following discharge from the hospital
Secondary	Time on Mechanical Ventilation	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.	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