Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery (CT0076)

Postoperative pulmonary complications are the most common complications after thoracic surgery. In the literature, pulmonary complications after thoracic surgery are present in more than 37.5% of patients. No study investigates the impact of preoperative inspiratory muscle exercises program on pulmonary complications after thoracic surgery.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: inspiratory muscle program

Detailed Description

Postoperative pulmonary complications are the most common complications after thoracic surgery. In the literature, pulmonary complications after thoracic surgery are present in more than 37.5% of patients. Pulmonary complications include atelectasia, pneumonia and respiratory failure.

In order to reduce the pulmonary complications, other surgical specialties, such as cardiac and esophagus surgeries, use preoperative inspiratory muscle training programs. No study investigates the impact of preoperative inspiratory muscle exercises program on pulmonary complications after thoracic surgery.

Project Design:

Randomized study on patients at-risk of pulmonary complications. Two parallel groups are recruited for comparison between preoperative inspiratory muscle training program and the standard of care (without preoperative inspiratory muscle training program). In the study, 2 groups of 100 patients each are recruited in thoracic clinic. A recruitment period of approximately 8 months is needed in order to establish if the inspiratory muscular training significantly reduce the pulmonary complications in the patients at-risk. The P. value to determine a significant impact is 0.05 with a power of 0.80. We aim to reduce pulmonary complications with the inspiratory muscle training program by 50%.

Randomization Method:

Computerized, secure and anonymous randomization using a secure information program.

Population under study:

Recruitment in thoracic clinic, during the initial consultation for a thoracic surgery in the department of thoracic surgery of the University of Montreal Hospital Center, of a total of 200 patients. One hundred patients in the preoperative inspiratory muscle training group and 100 patients in the control group with usual care preoperatively (standard of care).

The study population is at-risk of pulmonary complications patients. The risk factors of pulmonary complications are patients over 70 years, presence of cough and sputum, diabetes, active smoking, FEV1 (forced expiratory volume per second) less than 75% or under respiratory pump, body mass index over 27 kg / m2, FEV1 less than 80%, Tiffeneau index less than 70%, NYHA II (New York Heart Association Classification) or sleep apnea.

Analysis A comparison of pulmonary complications after surgery in patients who participated in the inspiratory muscle training program and a control group who will have the usual care of a postoperative thoracic surgery.

After surgery, perioperative follow-up including perioperative complications, duration of hospitalization and complications and mortality after 30 days of surgery.

Satisfaction and motivation will be assessed postoperatively at discharge and at 30-day postoperative follow-up.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X3E4
      • CHUM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to consent
• Pulmonary resection: segmental resection or lobectomy or bilobectomy
• With or without previous pulmonary resection
• Thoracotomy and minimally invasive surgery
• With or without neoadjuvant chemotherapy
• 1 or more risk factors for pulmonary complications (over 70 years, cough and sputum, diabetes, smoking, FEV1 less than 75% or under pump, BMI over 27 kg / m2, FEV1 less than 80%, TIFF less than 70%, NYHA II or sleep apnea)

Exclusion Criteria:

• Refusal of the patient
• Pregnancy
• Pneumonectomy
• FEV1 less than 30%
• DLCO less than 30%
• Vo2 MAX less than 10cc / min / kg
• Contraindication to respiratory physiotherapy - Myocardial infarction or cerebrovascular accident for less than 1 year, unstable angina, aneurysm, significant hemoptysis less than 90 days, muscular or neurological pathology constraining respiratory physiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inspiratory muscle program; Inspiratory muscle training preoperative with standard of care	Other: inspiratory muscle program; pre-operative inspiratory muscular training program
Other: no inspiratory muscle program; standard of care: postoperative spirometry with enhanced recovery program in thoracic surgery	Other: inspiratory muscle program; pre-operative inspiratory muscular training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Numbers of postoperative pulmonary complications	Up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Numbers of morbidity and mortality	Up to 30 days after surgery
Length of stay (by days)	Up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2019-7755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No