Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Not Applicable

• Conditions: Surgery; Pulmonary Complication; Surgery--Complications
• Interventions: Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

• Registration Number: NCT05134610
• Lead Sponsor: Western University, Canada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-14
• Study Start: 2022-03
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPEP Therapy	AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE	14 days pre- and and post-op OPEP device usage

Primary Outcome Measures

Name	Time	Method
Trial feasibility: limited efficacy of the OPEP device	18 months	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.
Trial feasibility: capacity for recruitment	18 months	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.
Trial feasibility: device adherence	18 months	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.
Trial feasibility: data collection	18 months	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.