Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients

Study Overview
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Brief Summary
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Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery (lobectomy etc, open or VATS) and cardiac surgery

Detailed Description
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Inspiratory force calibrated training is applied in a controlled randomized trial

Official Title
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Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients

Conditions
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Postoperative; Dysfunction Following Cardiac Surgery, Postoperative; Dysfunction Following Lung Surgery

Intervention / Treatment
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* Other: Chest Physiotherapy
* Device: Post-therapy lung volume measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cardiothoracic operation, informed consent Exclusion Criteria: reduced co-operation (such as psychiatric diagnosis), severe neurologic disease affecting respiratory function, alcohol or drug abuse at hospital entry, tuberculosis or other contagious lung infection, severe respiratory insufficiency SpO2 < 90 or blood pO2 <8 or rep.rate > 25/min at rest or supplementary oxygen required at home, cardiac pacemaker.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiotherapy w/Positive end expiratory pressure training<br>Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements | Other: Chest Physiotherapy<br> <br> Device: Post-therapy lung volume measurements<br>* In both intervention groups.<br>|
| Experimental: Physiotherapy w/Inspiratory force training<br>Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements | Other: Chest Physiotherapy<br> <br> Device: Post-therapy lung volume measurements<br>* In both intervention groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 | Serial measurements | Preop + 1-3 postoperative days | 
| Number of patients with atelectasis | In chest x-ray | Preop + 1-3 postoperative days | 
| Change in peripheral oxygen saturation | Serial measurements | Preop + 1-3 postoperative days | 
| Postoperative lung complications | Number of patients with lung infections, prolonged air leak, pneumothorax | Preop + 1-30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to Chest physiotherapy | Serial evaluations and measurements | Preop + 1-3 postoperative days |