Coronary Artery Bypass Graft SurgeryPRIMUSNCT04717817
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
A study testing Inspiratory muscle training (IMT) using an IMT Threshold device (Philips) and Standard physiotherapy in people with Coronary Artery Bypass Graft Surgery and Valve Replacement, run by Universitair Ziekenhuis Brussel.
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery, Valve Replacement, Post-Op Complications
- What is being tested?
- Inspiratory muscle training (IMT) using an IMT Threshold device (Philips) and Standard physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for coronary artery bypass grafting or minimally invasive valve repair/replacement
Who cannot join
- 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)
About this study
Official title: The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
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.
Read the 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).
- Conditions
- Coronary Artery Bypass Graft Surgery, Valve Replacement, Post-Op Complications, Physiotherapy
- Being tested
- Inspiratory muscle training (IMT) using an IMT Threshold device (Philips), Standard physiotherapy
- Keywords
- post-operative complications, inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)Device
Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks
Standard physiotherapyOther
Standard instructions and physiotherapy prior to surgery during 2-3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1: experimental | Experimental | Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery Receives: Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips) |
| Group 2: comparator | Active comparator | Standard physiotherapy prior to surgery Receives: Other: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function (Volumes)
Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction
Measured: Prior to 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 and evolution after pre-operative physiotherapy.
Measured: After 2 weeks of pre-operative physiotherapy (before surgery)
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.
Measured: approximately 6 days 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.
Measured: Prior to 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 and evolution after pre-operative physiotherapy.
Measured: After 2 weeks of pre-operative physiotherapy (before surgery)
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.
Measured: approximately 6 days after surgery
Secondary outcomes (12)
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.
Measured: early post-operative period (day0 - day7)
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Measured: Prior to pre-operative physiotherapy
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Measured: 3 days after surgery
Hand grip strength
Evaluation of hand grip strength using a Martin Vigorimeter
Measured: 6 days after surgery
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Measured: Prior the pre-operative physiotherapy
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Measured: After 1 week of pre-operative physiotherapy
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Measured: After 2 weeks of pre-operative physiotherapy (before surgery)
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Measured: 3 days after surgery
Respiratory Muscle Strength Test
Maximum inspiratory pressure (MIP)
Measured: 6 days after surgery
CRP
C-reactive protein, evaluation inflammatory status
Measured: Prior the pre-operative physiotherapy
CRP
C-reactive protein, evaluation inflammatory status
Measured: 3 days after surgery
CRP
C-reactive protein, evaluation inflammatory status
Measured: 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: lack of time and personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, Jessa Hospital
- Responsible party
- Sponsor
- Investigators
- Dirk Verdaet, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717817
- Sponsor's protocol ID
- 001/20200218
- Acronym
- PRIMUS
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRIMUS Study: Effect of Pre-operative Inspiratory Muscle Training on Post-operative Pulmonary Recovery and Pulmonary Complications After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04717817
- Acronym / sponsor ID
- PRIMUS / 001/20200218
- Conditions
- Coronary Artery Bypass Graft Surgery, Valve Replacement, Post-Op Complications, Physiotherapy
- Keywords
- post-operative complications, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of time and personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Hasselt University, Jessa Hospital
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: experimental | Experimental | Device: Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)Daily inspiratory muscle training (IMT) using an IMT Threshold device (Philips) prior to surgery |
| Group 2: comparator | Active comparator | Other: Standard physiotherapyStandard physiotherapy prior to surgery |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for coronary artery bypass grafting or minimally invasive valve repair/replacement
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks | Device | Group 1: experimental |
| Standard physiotherapyStandard instructions and physiotherapy prior to surgery during 2-3 weeks | Other | Group 2: comparator |
Primary outcome
Pulmonary function (Volumes)
Time frame: Prior to pre-operative physiotherapy
Inspiratory capacity (l), Functional residual capacity (l),Residual volume (l), Total lung capacity (l). Baseline. Diagnosis of normal/obstructive/restrictive lungfunction
Pulmonary function (Volumes)
Time frame: After 2 weeks of pre-operative physiotherapy (before surgery)
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)
Time frame: 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.
Dynamic pulmonary function
Time frame: Prior to pre-operative physiotherapy
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
Time frame: After 2 weeks of pre-operative physiotherapy (before surgery)
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
Time frame: 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.
12 secondary outcomes
post-operative pulmonary complications
Time frame: early post-operative period (day0 - day7)
Hand grip strength
Time frame: Prior to pre-operative physiotherapy
Hand grip strength
Time frame: 3 days after surgery
Hand grip strength
Time frame: 6 days after surgery
Respiratory Muscle Strength Test
Time frame: Prior the pre-operative physiotherapy
Respiratory Muscle Strength Test
Time frame: After 1 week of pre-operative physiotherapy
Respiratory Muscle Strength Test
Time frame: After 2 weeks of pre-operative physiotherapy (before surgery)
Respiratory Muscle Strength Test
Time frame: 3 days after surgery
Respiratory Muscle Strength Test
Time frame: 6 days after surgery
CRP
Time frame: Prior the pre-operative physiotherapy
CRP
Time frame: 3 days after surgery
CRP
Time frame: 6 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Verdaet principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT) using an IMT Threshold device (Philips) and Standard physiotherapy in people with Coronary Artery Bypass Graft Surgery and Valve Replacement, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (Volumes) (time frame: Prior to pre-operative physiotherapy). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.