Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Western University, Canada150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Pulmonary Complication Surgery--Complications Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 18 months

Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts