Heart SurgeryNCT00418158
Pulmonary Complications After Heart Surgery.
A study testing use of Airlife (therapy) in people with Heart Surgery, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Abstract: Post-operative pulmonary complications after cardiac surgery Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery
- What is being tested?
- use of Airlife (therapy)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2005to Jan 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Euroscore < 8
- Age > 18 year
- Patients whereby ECC is peri-operatively used
- No psychological history
- Informed consent obtained
- Follow -up at Catherina Hospital
Who cannot join
- COPD
- Mitral valve plasty or reconstruction
- Off-pump
- Cognitive problems
- Expected comlpications during operation
- Patients with decompensation
Show all 9Show fewer
- Day 5 post- ok thoracic drains insitu
- Pain score grater than 4
- Abnormal chest x-ray
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Complications After Heart Surgery
Abstract: Post-operative pulmonary complications after cardiac surgery
Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Two years ago they abolished the pulmonary support by a physiotherapist. Subjectively, the pulmonary complications increased over the last two years. During an investigation of the contentment of the patients an increase of the pulmonary problems came forward after eliminating the pulmonary support. There have been no further examinations to the pulmonary complications post-operatively.
Read more
Objectives The aim of this study is to give the department of cardio-thoracic surgery an advice about the post-operative pulmonary support for patients who underwent heart surgery.
During the study a budgetary analysis will be made.
Methods 120 patients are prospectively randomised in three groups. Randomisation takes place through block randomisation every three weeks. 40 patients will be supported by a physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a self-management method.
The study population are all patients undergoing heart surgery and spend their entire post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in the protocol on pages 3 and 4.
Outcome The primary outcome is to qualify the pulmonary complications within the three groups. These complications will be objectified by measuring peak flow, an instrument to determine the lung function, and an x-ray of the thorax.
The secondary outcome is the contentment of the patient, which will be determined by a VAS-score (Visual Analogue Scale).
Risks There are no risks for the patient when participating on this study. The patient will have to fill in the VAS-score and measure lung function with the peak flow at two different moments. The study takes place in a clinical setting. There is no extra insurance in conformity with the advice of the METC.
- Conditions
- Heart Surgery
- Being tested
- use of Airlife (therapy)
- Keywords
- Pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of Airlife (therapy)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Investigators
- F.J. ter Woorst, MD, Principal investigator, Catharina Hospital Eindhoven, department of CardioThoracic Surgery. The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418158
- Sponsor's protocol ID
- poho studie
- Status last verified
- Nov 2009
- First submitted
- 3 Jan 2007
- Last updated
- 10 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Complications After Heart Surgery
- ClinicalTrials.gov ID
- NCT00418158
- Acronym / sponsor ID
- poho studie
- Conditions
- Heart Surgery
- Keywords
- Pulmonary complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 4 Jan 2007 (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.
Abstract: Post-operative pulmonary complications after cardiac surgery
Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Two years ago they abolished the pulmonary support by a physiotherapist. Subjectively, the pulmonary complications increased over the last two years. During an investigation of the contentment of the patients an increase of the pulmonary problems came forward after eliminating the pulmonary support. There have been no further examinations to the pulmonary complications post-operatively.
Objectives The aim of this study is to give the department of cardio-thoracic surgery an advice about the post-operative pulmonary support for patients who underwent heart surgery.
During the study a budgetary analysis will be made.
Methods 120 patients are prospectively randomised in three groups. Randomisation takes place through block randomisation every three weeks. 40 patients will be supported by a physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a self-management method.
The study population are all patients undergoing heart surgery and spend their entire post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in the protocol on pages 3 and 4.
Outcome The primary outcome is to qualify the pulmonary complications within the three groups. These complications will be objectified by measuring peak flow, an instrument to determine the lung function, and an x-ray of the thorax.
The secondary outcome is the contentment of the patient, which will be determined by a VAS-score (Visual Analogue Scale).
Risks There are no risks for the patient when participating on this study. The patient will have to fill in the VAS-score and measure lung function with the peak flow at two different moments. The study takes place in a clinical setting. There is no extra insurance in conformity with the advice of the METC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Euroscore < 8
- Age > 18 year
- Patients whereby ECC is peri-operatively used
- No psychological history
- Informed consent obtained
Key exclusion criteria (9 listed)
- COPD
- Mitral valve plasty or reconstruction
- Off-pump
- Cognitive problems
- Expected comlpications during operation
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 |
|---|---|---|
| use of Airlife (therapy) | Behavioural | – |
Primary outcome
Not reported in the source record.
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 10 Nov 2009.
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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.
F.J. ter Woorst, MD principal investigator
Catharina Hospital Eindhoven, department of CardioThoracic Surgery. The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of Airlife (therapy) in people with Heart Surgery, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 6 inclusion and 9 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 10 Nov 2009. 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 Netherlands. 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.
Where can I read the original study information?
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 10 Nov 2009.