Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedOctober 13, 2016
October 1, 2016
2.5 years
December 9, 2015
October 10, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Compliance to Chest physiotherapy
Preop + 1-3 postoperative days
Study Arms (2)
Physiotherapy w/Positive end expiratory pressure training
ACTIVE COMPARATORChest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements
Physiotherapy w/Inspiratory force training
EXPERIMENTALChest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements
Interventions
In both intervention groups.
Eligibility Criteria
You may qualify if:
- cardiothoracic operation,
- informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Tampere University of Technologycollaborator
Study Sites (1)
Tampere University Hospital, Heart Center
Tampere, 33521, Finland
Related Publications (1)
Lahteenmaki S, Juutinen M, Viik J, Mahrberg H, Laurikka J. Effects of physiotherapy on breathing cycle after thoracic surgery measured with impedance pneumography in a prospective clinical comparison. Gen Thorac Cardiovasc Surg. 2025 Sep 26. doi: 10.1007/s11748-025-02199-y. Online ahead of print.
PMID: 41004114DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jari O Laurikka, MD,PhD
Tampere Univeristy Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2015
First Posted
October 13, 2016
Study Start
September 1, 2013
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10