Postoperative; Dysfunction Following Cardiac SurgeryNCT02931617
Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
A study testing Chest Physiotherapy and Post-therapy lung volume measurements in people with Postoperative; Dysfunction Following Cardiac Surgery and Postoperative; Dysfunction Following Lung Surgery, run by Tampere University Hospital at 1 site in Finland.
Trial 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 more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery, Postoperative; Dysfunction Following Lung Surgery
- What is being tested?
- Chest Physiotherapy and Post-therapy lung volume measurements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cardiothoracic operation,
- informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Postoperative; Dysfunction Following Cardiac Surgery, Postoperative; Dysfunction Following Lung Surgery
- Being tested
- Chest Physiotherapy, Post-therapy lung volume measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest PhysiotherapyOther
Post-therapy lung volume measurementsDevice
In both intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy w/Positive end expiratory pressure training | Active comparator | Chest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements Receives: Other: Chest Physiotherapy; Device: Post-therapy lung volume measurements |
| Physiotherapy w/Inspiratory force training | Experimental | Chest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements Receives: Other: Chest Physiotherapy; Device: Post-therapy lung volume measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1
Serial measurements
Measured: Preop + 1-3 postoperative days
Number of patients with atelectasis
In chest x-ray
Measured: Preop + 1-3 postoperative days
Change in peripheral oxygen saturation
Serial measurements
Measured: Preop + 1-3 postoperative days
Postoperative lung complications
Number of patients with lung infections, prolonged air leak, pneumothorax
Measured: Preop + 1-30 postoperative days
Secondary outcomes (1)
Compliance to Chest physiotherapy
Serial evaluations and measurements
Measured: Preop + 1-3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative; Dysfunction Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology
- Responsible party
- Sponsor
- Investigators
- Jari O Laurikka, MD,PhD, Principal investigator, Tampere Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931617
- Sponsor's protocol ID
- ETLR13037
- Status last verified
- Oct 2016
- First submitted
- 9 Dec 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Miri S, Lahteenmaki S, Mahrberg H, Vehkaoja A, Laurikka J, Viik J. Quantification of Immediate Surgical Stress After Major and Minor Thoracic Surgeries Through HRV: A Secondary Post Hoc Analysis of a Randomized Controlled Trial. Pulm Med. 2026;2026(1):e3752161. doi: 10.1155/pm/3752161.
PubMed 42813902Lahteenmaki 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. 2026 Mar;74(3):286-294. doi: 10.1007/s11748-025-02199-y. Epub 2025 Sep 26.
PubMed 41004114
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
- ClinicalTrials.gov ID
- NCT02931617
- Acronym / sponsor ID
- ETLR13037
- Conditions
- Postoperative; Dysfunction Following Cardiac Surgery, Postoperative; Dysfunction Following Lung Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Inspiratory force calibrated training is applied in a controlled randomized trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy w/Positive end expiratory pressure training | Active comparator | Other: Chest Physiotherapy, Device: Post-therapy lung volume measurementsChest Physiotherapy w/Positive end expiratory pressure training; post therapy lung volume measurements |
| Physiotherapy w/Inspiratory force training | Experimental | Other: Chest Physiotherapy, Device: Post-therapy lung volume measurementsChest Physiotherapy w/Inspiratory force training; post therapy lung volume measurements |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cardiothoracic operation,
- informed consent
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Physiotherapy | Other | Physiotherapy w/Inspiratory force training, Physiotherapy w/Positive end expiratory pressure training |
| Post-therapy lung volume measurementsIn both intervention groups. | Device | Physiotherapy w/Inspiratory force training, Physiotherapy w/Positive end expiratory pressure training |
Primary outcome
Change in FEV1
Time frame: Preop + 1-3 postoperative days
Serial measurements
Number of patients with atelectasis
Time frame: Preop + 1-3 postoperative days
In chest x-ray
Change in peripheral oxygen saturation
Time frame: Preop + 1-3 postoperative days
Serial measurements
Postoperative lung complications
Time frame: Preop + 1-30 postoperative days
Number of patients with lung infections, prolonged air leak, pneumothorax
1 secondary outcome
Compliance to Chest physiotherapy
Time frame: Preop + 1-3 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 42813902Miri S, Lahteenmaki S, Mahrberg H, Vehkaoja A, Laurikka J, Viik J. Quantification of Immediate Surgical Stress After Major and Minor Thoracic Surgeries Through HRV: A Secondary Post Hoc Analysis of a Randomized Controlled Trial. Pulm Med. 2026;2026(1):e3752161. doi: 10.1155/pm/3752161.
- Derived from this study: PubMed 41004114Lahteenmaki 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. 2026 Mar;74(3):286-294. doi: 10.1007/s11748-025-02199-y. Epub 2025 Sep 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari O Laurikka, MD,PhD principal investigator
Tampere Univeristy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Physiotherapy and Post-therapy lung volume measurements in people with Postoperative; Dysfunction Following Cardiac Surgery and Postoperative; Dysfunction Following Lung Surgery, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 (time frame: Preop + 1-3 postoperative days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02931617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.