Coronary Artery Bypass Graft Surgery, Physiotherapy, Post-Op Complications, Valve Replacement
Conditions
Keywords
post-operative complications, inspiratory muscle training
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).
Interventions
DEVICEInspiratory muscle training (IMT) using an IMT Threshold device (Philips)
Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks
OTHERStandard physiotherapy
Standard instructions and physiotherapy prior to surgery during 2-3 weeks
Sponsors
Hasselt University
Jessa Hospital
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
lungfunction assessor, radiologist (thorax X-ray) and physician (hospital ward) are blinded
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic pulmonary function | 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. |
| Pulmonary function (Volumes) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip strength | Prior to pre-operative physiotherapy | Evaluation of hand grip strength using a Martin Vigorimeter |
| CRP | Prior the pre-operative physiotherapy | C-reactive protein, evaluation inflammatory status |
| Respiratory Muscle Strength Test | Prior the pre-operative physiotherapy | Maximum inspiratory pressure (MIP) |
| post-operative pulmonary complications | early post-operative period (day0 - day7) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frailty | basline, Prior the pre-operative physiotherapy | Frailty measured by the SHARE-FI, SHARE Frailty instrument |
Outcome results
None listed