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The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
The main objective of this study is to evaluate the effect of pre-operative Inspiratory muscle training (IMT) using an IMT Threshold device (Philips), on early postoperative lung function recovery and on the occurrence of post-operative pulmonary complications (PPC) after major cardiothoracic surgery with and without sternotomy. As frailty can affect postoperative outcome, the relation between frailty, maximal inspiratory pressure (MIP) and post-operative outcome is investigated additionally.
Patients eligible for cardiac surgery are pre-operatively randomized to standard physiotherapy or daily inspiratory muscle training for a period of 2-3 weeks. One therapy session a week is supervised by a physiotherapist in the IMT group. Post-operative physiotherapy is standardized. Pulmonary function and clinical status are evaluated pre-operatively, and during the early post-operative phase, approximately on the 3th and 6th post-operative day, or when necessary. The occurrence of postopercenterative pulmonary complications is determined using a validated scale, the Melbourne group scale, based on clinical status, chest x-ray and blood tests. Frailty is defined based on the Fried criteria. Two Belgian hospitals are involved in this study: the University Hospital Brussels and the Jessa Hospital (Hasselt), the latter mainly focussing on patients referred for minimal invasive heart surgery (minimally invasive-aortic valve replacement (mini-AVR) and Endoscopic - Atraumatic Coronary Artery Bypass (endo-ACAB).
Age
20 - 85 years
Sex
ALL
Healthy Volunteers
No
Start Date
February 1, 2023
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2025
Last Updated
December 12, 2023
Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)
DEVICE
Standard physiotherapy
OTHER
Lead Sponsor
Universitair Ziekenhuis Brussel
Collaborators
NCT03636295
NCT07059793
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06403839