Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery

Physiotherapy Clinical Trial

— PRIMUS  

Official title:

The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04717817
• Other study ID #: 001/20200218
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery
• Physiotherapy
• Post-Op Complications
• Postoperative Complications
• Respiratory Aspiration
• Valve Replacement

Intervention

Device:
• Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)
Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks

Other:
• Standard physiotherapy
Standard instructions and physiotherapy prior to surgery during 2-3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Hasselt University, Jessa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frailty	Frailty measured by the SHARE-FI, SHARE Frailty instrument	basline, Prior the pre-operative physiotherapy
Primary	Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction	Prior to pre-operative physiotherapy
Primary	Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l), Residual volume (l), Total lung capacity (l).Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.	After 2 weeks of pre-operative physiotherapy (before surgery)
Primary	Pulmonary function (Volumes)	Inspiratory capacity (l), Functional residual capacity (l) ,Residual volume (l),Total lung capacity (l). Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.	approximately 6 days after surgery
Primary	Dynamic pulmonary function	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction.	Prior to pre-operative physiotherapy
Primary	Dynamic pulmonary function	Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Diagnosis of normal/obstructive/restrictive lungfunction and evolution after pre-operative physiotherapy.	After 2 weeks of pre-operative physiotherapy (before surgery)
Primary	Dynamic pulmonary function	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.	approximately 6 days after surgery
Secondary	post-operative pulmonary complications	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.	early post-operative period (day0 - day7)
Secondary	Hand grip strength	Evaluation of hand grip strength using a Martin Vigorimeter	Prior to pre-operative physiotherapy
Secondary	Hand grip strength	Evaluation of hand grip strength using a Martin Vigorimeter	3 days after surgery
Secondary	Hand grip strength	Evaluation of hand grip strength using a Martin Vigorimeter	6 days after surgery
Secondary	Respiratory Muscle Strength Test	Maximum inspiratory pressure (MIP)	Prior the pre-operative physiotherapy
Secondary	Respiratory Muscle Strength Test	Maximum inspiratory pressure (MIP)	After 1 week of pre-operative physiotherapy
Secondary	Respiratory Muscle Strength Test	Maximum inspiratory pressure (MIP)	After 2 weeks of pre-operative physiotherapy (before surgery)
Secondary	Respiratory Muscle Strength Test	Maximum inspiratory pressure (MIP)	3 days after surgery
Secondary	Respiratory Muscle Strength Test	Maximum inspiratory pressure (MIP)	6 days after surgery
Secondary	CRP	C-reactive protein, evaluation inflammatory status	Prior the pre-operative physiotherapy
Secondary	CRP	C-reactive protein, evaluation inflammatory status	3 days after surgery
Secondary	CRP	C-reactive protein, evaluation inflammatory status	6 days after surgery