CClinicalTrials.gg
CompletedNCT02931617Updated Oct 13, 2016

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

An interventional study of Chest Physiotherapy and Post-therapy lung volume measurements in Postoperative; Dysfunction Following Cardiac Surgery and Postoperative; Dysfunction Following Lung Surgery, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-10-13.

Sponsored by Tampere University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 99 Years
Sex
All
01

Study 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

Read the detailed description

Inspiratory force calibrated training is applied in a controlled randomized trial

02

Conditions studied

  • Postoperative; Dysfunction Following Cardiac Surgery
  • Postoperative; Dysfunction Following Lung Surgery
03

In context

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cardiothoracic operation,
  • informed consent

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherChest Physiotherapy
  • DevicePost-therapy lung volume measurements

    In both intervention groups.

06

What researchers measure

Primary outcomes

  1. Change in FEV1

    Serial measurements

    Time frame: Preop + 1-3 postoperative days

  2. Number of patients with atelectasis

    In chest x-ray

    Time frame: Preop + 1-3 postoperative days

  3. Change in peripheral oxygen saturation

    Serial measurements

    Time frame: Preop + 1-3 postoperative days

  4. Postoperative lung complications

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

    Time frame: Preop + 1-30 postoperative days

Secondary outcomes

  1. Compliance to Chest physiotherapy

    Serial evaluations and measurements

    Time frame: Preop + 1-3 postoperative days

07

Study locations

1 site
  • Tampere University Hospital, Heart Center
    Tampere, 33521, Finland
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02931617
Lead sponsor
Tampere University Hospital
Collaborators
Tampere University of Technology
Responsible party
Sponsor
First posted
Oct 13, 2016
Start date
Sep 2013
Primary completion
Mar 2016
Completion
Apr 2016
Last update
Oct 13, 2016

Study contacts

Jari O Laurikka, MD,PhD
principal investigator · Tampere Univeristy Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion