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Completed

NCT Number: NCT02931617

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

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Key information

Conditions

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

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital, Heart Center

Tampere, 33521, Finland

About this study

Inspiratory force calibrated training is applied in a controlled randomized trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chest physiotherapy

Other

Post-therapy lung volume measurements

Device

In both intervention groups.

Primary outcomes

  1. Change in FEV1

    Time frame: Preop + 1-3 postoperative days

    Serial measurements

  2. Number of patients with atelectasis

    Time frame: Preop + 1-3 postoperative days

    In chest x-ray

  3. Change in peripheral oxygen saturation

    Time frame: Preop + 1-3 postoperative days

    Serial measurements

  4. Postoperative lung complications

    Time frame: Preop + 1-30 postoperative days

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

Secondary outcomes

  1. Compliance to Chest physiotherapy

    Time frame: Preop + 1-3 postoperative days

    Serial evaluations and measurements

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University of Technology

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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