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

Not Applicable

Completed

• Conditions: Postoperative; Dysfunction Following Cardiac Surgery; Postoperative; Dysfunction Following Lung Surgery
• Interventions: Other: Chest Physiotherapy; Device: Post-therapy lung volume measurements

• Registration Number: NCT02931617
• Lead Sponsor: Tampere University Hospital

Brief Summary

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

Inspiratory force calibrated training is applied in a controlled randomized trial

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-12-09
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy w/Positive end expiratory pressure training	Chest Physiotherapy	Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements
Physiotherapy w/Inspiratory force training	Post-therapy lung volume measurements	Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements
Physiotherapy w/Positive end expiratory pressure training	Post-therapy lung volume measurements	Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements
Physiotherapy w/Inspiratory force training	Chest Physiotherapy	Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compliance to Chest physiotherapy	Preop + 1-3 postoperative days	Serial evaluations and measurements

Trial Locations

Locations (1)

Tampere University Hospital, Heart Center; 🇫🇮 Tampere, Finland