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

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

Study Overview

• Status: Completed
• Conditions: Postoperative; Dysfunction Following Cardiac Surgery; Postoperative; Dysfunction Following Lung Surgery
• Intervention / Treatment: Other: Chest Physiotherapy; Device: Post-therapy lung volume measurements

Detailed Description

Inspiratory force calibrated training is applied in a controlled randomized trial

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital, Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University of Technology
• Investigators: Principal Investigator: Jari O Laurikka, MD,PhD, Tampere Univeristy Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ETLR13037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided