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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04717817
Other study ID # 001/20200218
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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)

Study Design


Related Conditions & MeSH terms


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
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