Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery (PRIMUS)

Universitair Ziekenhuis Brussel

Status: Withdrawn

Conditions: Coronary Artery Bypass Graft Surgery; Physiotherapy; Valve Replacement; Post-Op Complications

Treatments: Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips); Other: Standard physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04717817

001/20200218

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Group 1: experimental

Experimental group

Description:

Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery

Treatment:

Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)

Group 2: comparator

Active Comparator group

Description:

Standard physiotherapy prior to surgery

Treatment:

Other: Standard physiotherapy