Effect of Perioperative OPEP Therapy on Post-operative Pulmonary Complications

NCT05134610 | Unknown FDA Device

• 1 other identifier: 116736
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Complication; Surgery--Complications; Surgery

Keywords

oscillating pulmonary expiratory pressure therapy; OPEP

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

OPEP Therapy

EXPERIMENTAL

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

Device: AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE

Interventions

AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE DEVICE

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

OPEP Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western University, Canada: lead

Central Study Contacts

Jeff Metz, MD

CONTACT

4169533991; jeffmetz2@gmail.com

Nawar Alkhamesi, MD

CONTACT

1-519-663-3985; Nawar.Alkhamesi@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: November 26, 2021
• Study Start: March 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 14, 2022

Record last verified: 2022-01