Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Complication Surgery--Complications Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Standard of care for pre- and post-op pulmonary care

Group Type NO_INTERVENTION

No interventions assigned to this group

OPEP Therapy

14 days pre- and and post-op OPEP device usage

Group Type EXPERIMENTAL

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

Intervention Type DEVICE

Intervention arm patients use the OPEP device twice daily for 2 weeks before and after surgery

Interventions

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AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

Intervention arm patients use the OPEP device twice daily for 2 weeks before and after surgery

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No