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Clinical Trials/NCT02931617
NCT02931617CompletedNot Applicable

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

Tampere University Hospital1 site in 1 country120 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
Number of patients with atelectasis

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
16 Years to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Physiotherapy w/Positive end expiratory pressure training

Active Comparator

Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements

Intervention: Chest Physiotherapy (Other)

Physiotherapy w/Positive end expiratory pressure training

Active Comparator

Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements

Intervention: Post-therapy lung volume measurements (Device)

Physiotherapy w/Inspiratory force training

Experimental

Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements

Intervention: Chest Physiotherapy (Other)

Physiotherapy w/Inspiratory force training

Experimental

Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements

Intervention: Post-therapy lung volume measurements (Device)

Outcomes

Primary Outcomes

Number of patients with atelectasis

Time Frame: Preop + 1-3 postoperative days

In chest x-ray

Change in peripheral oxygen saturation

Time Frame: Preop + 1-3 postoperative days

Serial measurements

Postoperative lung complications

Time Frame: Preop + 1-30 postoperative days

Number of patients with lung infections, prolonged air leak, pneumothorax

Change in FEV1

Time Frame: Preop + 1-3 postoperative days

Serial measurements

Secondary Outcomes

  • Compliance to Chest physiotherapy(Preop + 1-3 postoperative days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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