Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Study Overview
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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.

Official Title
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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

Conditions
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Pulmonary Complication, Surgery--Complications, Surgery

Intervention / Treatment
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* Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care for pre- and post-op pulmonary care | |
| Experimental: OPEP Therapy<br>14 days pre- and and post-op OPEP device usage | Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE<br>* Intervention arm patients use the OPEP device twice daily for 2 weeks before and after surgery<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oscillating pulmonary expiratory pressure therapy, OPEP