An interventional study of inspiratory muscle program in Lung Cancer, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Prevention
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.
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 141 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inspiratory muscle training preoperative with standard of care
Other: 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
Numbers of postoperative pulmonary complications
Time frame: Up to 30 days after surgery
Numbers of morbidity and mortality
Time frame: Up to 30 days after surgery
Length of stay (by days)
Time frame: Up to 30 days after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)