Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03747380 |
| Other study ID # |
2019-7755 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2019 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
