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

Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931617
• Other study ID #: ETLR13037
• Status: Completed
• Phase: N/A
• First received: December 9, 2015
• Last updated: October 10, 2016
• Start date: September 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

Inspiratory force calibrated training is applied in a controlled randomized trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery
• Postoperative; Dysfunction Following Lung Surgery

Intervention

Other:
• Chest Physiotherapy

Device:
• Post-therapy lung volume measurements
In both intervention groups.

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Heart Center	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University of Technology

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1	Serial measurements	Preop + 1-3 postoperative days	Yes
Primary	Number of patients with atelectasis	In chest x-ray	Preop + 1-3 postoperative days	Yes
Primary	Change in peripheral oxygen saturation	Serial measurements	Preop + 1-3 postoperative days	No
Primary	Postoperative lung complications	Number of patients with lung infections, prolonged air leak, pneumothorax	Preop + 1-30 postoperative days	Yes
Secondary	Compliance to Chest physiotherapy	Serial evaluations and measurements	Preop + 1-3 postoperative days	No