Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery

Not Applicable

Withdrawn

• Conditions: Valve Replacement; Physiotherapy; Post-Op Complications; Coronary Artery Bypass Graft Surgery
• Interventions: Other: Standard physiotherapy; Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)

• Registration Number: NCT04717817
• Lead Sponsor: Universitair Ziekenhuis Brussel

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).

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-22
• Status Verified: 2022-11
• Study Start: 2023-02-01
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: comparator	Standard physiotherapy	Standard physiotherapy prior to surgery
Group 1: experimental	Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)	Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery

Primary Outcome Measures

Name	Time	Method
Dynamic pulmonary function	approximately 6 days after surgery	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l).Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.
Pulmonary function (Volumes)	approximately 6 days after surgery	Inspiratory capacity (l), Functional residual capacity (l) ,Residual volume (l),Total lung capacity (l). Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.

Secondary Outcome Measures

Name	Time	Method
Respiratory Muscle Strength Test	6 days after surgery	Maximum inspiratory pressure (MIP)
Hand grip strength	6 days after surgery	Evaluation of hand grip strength using a Martin Vigorimeter
CRP	6 days after surgery	C-reactive protein, evaluation inflammatory status
post-operative pulmonary complications	early post-operative period (day0 - day7)	Melbourne Group Scale (MGS), tool for recognition of postoperative pulmonary complications (PPC), based on 1) Temperature \>38◦C 2)White blood cell count \>11.2 or the use of respiratory antibiotics 3)Physician diagnosis of pneumonia or chest infection 4)Chest X-ray report of atelectasis/pneumonia 5)Production of purulent (yellow/green)sputum differing from preoperative 6)Positive signs on sputum microbiology 7)SpO2\<90% on room air 8)Re-admission to or prolonged stay (over36 hours) on the intensive care unit/highdependency unit for respiratory problems. Postoperative pulmonary complications are defined as a score of four or more positive variables. the occurence of PPC is an endpoint in this study.