Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Effectiveness of Perioperative Oscillating Positive Expiratory Pressure (OPEP) Therapy in Reduction of Post-operative Respiratory Morbidity in Patients Undergoing Colorectal Surgery: a Pilot Randomized Control Trial

For patients undergoing colorectal surgery, post-operative pulmonary complications (PPCs) are common. PPCs are associated with increased morbidity and mortality, as well as prolonged hospital stays and healthcare costs. Pulmonary exercise in the pre-operative setting is thought to improve pulmonary fitness and decrease incidence of PPCs. Use of an oscillating positive expiratory pressure (OPEP) device sees patients improve their respiratory fitness through prescribed usage of a handheld instrument that exercises pulmonary muscles while breathing. Here, the investigators propose a pilot randomized-controlled trial (RCT) to evaluate the feasibility of a large scale study that would examine the effect of preoperative OPEP device exercises in preventing PPCs for patients undergoing elective colorectal surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Surgery--Complications; Pulmonary Complication
• Intervention / Treatment: Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeff Metz, MD; Phone Number: 4169533991; Email: jeffmetz2@gmail.com
• Study Contact Backup: Name: Nawar Alkhamesi, MD; Phone Number: 1-519-663-3985; Email: Nawar.Alkhamesi@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be 18 years of age or older, and scheduled for an elective colorectal procedure at London Health Science Center (LHSC). Informed consent must be obtained.

Exclusion Criteria:

• Patients unable to perform written consent will be excluded. The investigators will not include colorectal procedures performed for urgent or emergent indications. Patients with advanced pulmonary disease necessitating home oxygen pre-operatively will be excluded. Patients that are pregnant will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Standard of care for pre- and post-op pulmonary care
EXPERIMENTAL: OPEP Therapy; 14 days pre- and and post-op OPEP device usage	Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE; Intervention arm patients use the OPEP device twice daily for 2 weeks before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial feasibility: capacity for recruitment	Ability of clinics to recruit patients in a timely manner. To be reported as a percent of the desired number of patients recruited over an 18 month period.	18 months
Trial feasibility: device adherence	Adherence of enrolled patients to usage of the OPEP device. To be reported as percent of patients returning a complete logbook detailing their consistent use of the OPEP device pre-op and post-op.	18 months
Trial feasibility: data collection	3) Completeness of data collected from enrolled patients medical record. To be reported as a percent of recruited patients with complete datasets following the trials completion. Used to identify gaps in data for a future fully powered trial.	18 months
Trial feasibility: limited efficacy of the OPEP device	Limited efficacy of the OPEP device to decrease post-operative pulmonary complications (PPCs). PPCs represents a composite outcome including atelectasis, pneumonia, prolonged requirement for supplemental oxygen, and respiratory failure.	18 months

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (ACTUAL): November 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: OPEP; oscillating pulmonary expiratory pressure therapy
• Other Study ID Numbers: 116736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No