Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery (CT0076)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
inspiratory muscle program
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
- CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
inspiratory muscle program
no inspiratory muscle program
Arm Description
Inspiratory muscle training preoperative with standard of care
standard of care: postoperative spirometry with enhanced recovery program in thoracic surgery
Outcomes
Primary Outcome Measures
Numbers of postoperative pulmonary complications
Secondary Outcome Measures
Numbers of morbidity and mortality
Length of stay (by days)
Full Information
NCT ID
NCT03747380
First Posted
September 13, 2018
Last Updated
February 14, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03747380
Brief Title
Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery
Acronym
CT0076
Official Title
Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inspiratory muscle program
Arm Type
Experimental
Arm Description
Inspiratory muscle training preoperative with standard of care
Arm Title
no inspiratory muscle program
Arm Type
Other
Arm Description
standard of care: postoperative spirometry with enhanced recovery program in thoracic surgery
Intervention Type
Other
Intervention Name(s)
inspiratory muscle program
Intervention Description
pre-operative inspiratory muscular training program
Primary Outcome Measure Information:
Title
Numbers of postoperative pulmonary complications
Time Frame
Up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Numbers of morbidity and mortality
Time Frame
Up to 30 days after surgery
Title
Length of stay (by days)
Time Frame
Up to 30 days after surgery
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moishe Liberman, MD, PhD
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X3E4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery
We'll reach out to this number within 24 hrs