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

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ClinicalTrials.gov Identifier: NCT03747380
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Other: inspiratory muscle program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-operative Inspiratory Muscle Training Program to Prevent Pulmonary Complications After Thoracic Surgery
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Numbers of postoperative pulmonary complications [ Time Frame: Up to 30 days after surgery ]

Secondary Outcome Measures :
  1. Numbers of morbidity and mortality [ Time Frame: Up to 30 days after surgery ]
  2. Length of stay (by days) [ Time Frame: Up to 30 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747380


Contacts
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Contact: Anny Godin, MD 514-895-8938 anny.godin@umontreal.ca
Contact: Moishe Liberman, MD, PhD 514-890-8000 ext 26832 moishe.liberman@umontreal.ca

Locations
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Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada, H2X3E4
Contact: Moishe Liberman, MD    514-890-8000 ext 26832    moishe.liberman@umontreal.ca   
Contact: Adeline Jouquan, MSc    514-890-8000 ext 26214    adeline.jouquan.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Moishe Liberman, MD, PhD CHUM
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03747380    
Other Study ID Numbers: 2019-7755
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes