Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery (PRIMUS)
Primary Purpose
Coronary Artery Bypass Graft Surgery, Valve Replacement, Post-Op Complications
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)
Standard physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Bypass Graft Surgery focused on measuring post-operative complications, inspiratory muscle training
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: experimental
Group 2: comparator
Arm Description
Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery
Standard physiotherapy prior to surgery
Outcomes
Primary Outcome Measures
Pulmonary function (Volumes)
Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
CRP
C-reactive protein, evaluation inflammatory status
CRP
C-reactive protein, evaluation inflammatory status
CRP
C-reactive protein, evaluation inflammatory status
Full Information
NCT ID
NCT04717817
First Posted
January 5, 2021
Last Updated
June 8, 2021
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Hasselt University, Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04717817
Brief Title
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
Acronym
PRIMUS
Official Title
The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Hasselt University, Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Surgery, Valve Replacement, Post-Op Complications, Physiotherapy
Keywords
post-operative complications, inspiratory muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
lungfunction assessor, radiologist (thorax X-ray) and physician (hospital ward) are blinded
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: experimental
Arm Type
Experimental
Arm Description
Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery
Arm Title
Group 2: comparator
Arm Type
Active Comparator
Arm Description
Standard physiotherapy prior to surgery
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)
Intervention Description
Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy
Intervention Description
Standard instructions and physiotherapy prior to surgery during 2-3 weeks
Primary Outcome Measure Information:
Title
Pulmonary function (Volumes)
Description
Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction
Time Frame
Prior to pre-operative physiotherapy
Title
Pulmonary function (Volumes)
Description
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.
Time Frame
After 2 weeks of pre-operative physiotherapy (before surgery)
Title
Pulmonary function (Volumes)
Description
Inspiratory capacity (l), Functional residual capacity (l) ,Residual volume (l),Total lung capacity (l). Diagnosis of normal/obstructive/restrictive lungfunction. Evolution after surgery.
Time Frame
approximately 6 days after surgery
Title
Dynamic pulmonary function
Description
Vital capacity (l), FVC: forced vital capacity (l), FEV1: forced expiratory volume in 1 second (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction.
Time Frame
Prior to pre-operative physiotherapy
Title
Dynamic pulmonary function
Description
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.
Time Frame
After 2 weeks of pre-operative physiotherapy (before surgery)
Title
Dynamic pulmonary function
Description
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.
Time Frame
approximately 6 days after surgery
Secondary Outcome Measure Information:
Title
post-operative pulmonary complications
Description
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.
Time Frame
early post-operative period (day0 - day7)
Title
Hand grip strength
Description
Evaluation of hand grip strength using a Martin Vigorimeter
Time Frame
Prior to pre-operative physiotherapy
Title
Hand grip strength
Description
Evaluation of hand grip strength using a Martin Vigorimeter
Time Frame
3 days after surgery
Title
Hand grip strength
Description
Evaluation of hand grip strength using a Martin Vigorimeter
Time Frame
6 days after surgery
Title
Respiratory Muscle Strength Test
Description
Maximum inspiratory pressure (MIP)
Time Frame
Prior the pre-operative physiotherapy
Title
Respiratory Muscle Strength Test
Description
Maximum inspiratory pressure (MIP)
Time Frame
After 1 week of pre-operative physiotherapy
Title
Respiratory Muscle Strength Test
Description
Maximum inspiratory pressure (MIP)
Time Frame
After 2 weeks of pre-operative physiotherapy (before surgery)
Title
Respiratory Muscle Strength Test
Description
Maximum inspiratory pressure (MIP)
Time Frame
3 days after surgery
Title
Respiratory Muscle Strength Test
Description
Maximum inspiratory pressure (MIP)
Time Frame
6 days after surgery
Title
CRP
Description
C-reactive protein, evaluation inflammatory status
Time Frame
Prior the pre-operative physiotherapy
Title
CRP
Description
C-reactive protein, evaluation inflammatory status
Time Frame
3 days after surgery
Title
CRP
Description
C-reactive protein, evaluation inflammatory status
Time Frame
6 days after surgery
Other Pre-specified Outcome Measures:
Title
Frailty
Description
Frailty measured by the SHARE-FI, SHARE Frailty instrument
Time Frame
basline, Prior the pre-operative physiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Verdaet
Phone
2 477 6025
Ext
0032
Email
dirk.verdaet@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Hansen, Professor
Phone
11 29 21 26
Ext
0032
Email
dominique.hansen@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Verdaet
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
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