Clinical trial NCT04717817: Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
Official title: The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery
Valve Replacement
Post-Op Complications
Physiotherapy
Keywords: post-operative complications
inspiratory muscle training
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Hasselt University
name: Jessa Hospital
First posted: 2021-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Candidates for coronary artery bypass grafting or minimally invasive valve repair/replacement

Exclusion Criteria:

* Not able to perform pre-operative standard pulmonary function tests
* No understanding of Dutch, French or English and/or no ability to understand verbal instructions regarding the inspiratory muscle training
* Patients who participate in another clinical trial
* Patients suffering from neuromuscular disorders, unstable angina, a history of non-traumatic pneumothorax, chronic obstructive pulmonary disease (COPD) in exacerbation
* Patients in need for urgent surgery (within less than 2 weeks)

Primary outcomes:
measure: Pulmonary function (Volumes)
timeFrame: Prior to pre-operative physiotherapy
measure: Pulmonary function (Volumes)
timeFrame: After 2 weeks of pre-operative physiotherapy (before surgery)
measure: Pulmonary function (Volumes)
timeFrame: approximately 6 days after surgery
measure: Dynamic pulmonary function
timeFrame: Prior to pre-operative physiotherapy
measure: Dynamic pulmonary function
timeFrame: After 2 weeks of pre-operative physiotherapy (before surgery)
measure: Dynamic pulmonary function
timeFrame: approximately 6 days after surgery
Secondary outcomes:
measure: post-operative pulmonary complications
timeFrame: early post-operative period (day0 - day7)
measure: Hand grip strength
timeFrame: Prior to pre-operative physiotherapy
measure: Hand grip strength
timeFrame: 3 days after surgery
measure: Hand grip strength
timeFrame: 6 days after surgery
measure: Respiratory Muscle Strength Test
timeFrame: Prior the pre-operative physiotherapy
measure: Respiratory Muscle Strength Test
timeFrame: After 1 week of pre-operative physiotherapy
measure: Respiratory Muscle Strength Test
timeFrame: After 2 weeks of pre-operative physiotherapy (before surgery)
measure: Respiratory Muscle Strength Test
timeFrame: 3 days after surgery
measure: Respiratory Muscle Strength Test
timeFrame: 6 days after surgery
measure: CRP
timeFrame: Prior the pre-operative physiotherapy
measure: CRP
timeFrame: 3 days after surgery
measure: CRP
timeFrame: 6 days after surgery
Other outcomes:
measure: Frailty
timeFrame: basline, Prior the pre-operative physiotherapy
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Dirk Verdaet
role: PRINCIPAL_INVESTIGATOR
References: