Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
Official title:
Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
Verified date | October 2016 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital, Heart Center | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital | Tampere University of Technology |
Finland,
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 |
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