Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04717817
Status:
WITHDRAWN
Last Update Posted:
2023-12-12
First Post:
2021-01-05
Brief Title:
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
The PRIMUS Study Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of time and personnel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMUS
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None