Thoracic SurgeryCOMPLINCT02654600
Variations of the Lung Compliance During Extracorporeal Circulation and Post Operative Pulmonary Complications
An observational study of Thoracic Surgery and Cardiopulmonary Bypass, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Cardiopulmonary Bypass
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Jun 2016
- Phase
- Observational
- 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
Study population: Every ASA 2 or 3 patient eligible for non-complex and non-urgent cardiac surgery
Who may be able to join
- scheduled for standard aortic
- mitral or coronary surgery
Who cannot join
- emergency operation
- no complete preoperative echocardiography
- surgery needing multiple table position changes
- unstable cardiac or respiratory condition
- difficult patient needing multiple care and/or special attention
Trial locations and contacts
1 site in 1 country.
About this study
the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through pulmonary blood emptying.
Read the detailed description
compliance is the compliance calculate when thorax is closed, the pulmonary compliance is the compliance calculated when thorax is opened After operation chest X-ray are daily done and blood samples as needed. Were recorded death, time of extubation,duration of non invasive ventilation,of Intensive Care Unit stay and of total hospital stay, troponin peak, lactates, blood gases, ionogram and count.Variations of compliance is analyzed through one factor paired Anova or Wilcoxon paired test. Decrease of compliance and respiratory complications are analyzed through binomial logistic regression.
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- cardiac surgery, thoracopulmonary compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary compliance during cardiac surgery
compliance is calculated by dividing tidal volume (ml) by the difference between plateau-inspiratory pressure (mmHg) and end-expiratory pressure (mmHg) before ,during and after CBP
Measured: intraoperative
Secondary outcomes (2)
pulmonary complications including death after cardiac surgery
intersticial and/or alveolar pulmonary oedema leading to death or extra hospital stay
Measured: 1 month
thoracopulmonary compliance during cardiac surgery
compliance is calculated by dividing tidal volume (ml) by the difference between peak-inspiratory pressure (mmHg) and end-expiratory pressure (mmHg) before ,during and after CBP
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 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 Thoracic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654600
- Sponsor's protocol ID
- P14-37816002/2014-A00702-45
- Acronym
- COMPLI
- Status last verified
- May 2017
- First submitted
- 2 Sep 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellison LT, Duke JF 3rd, Ellison RG. Pulmonary compliance following open-heart surgery and its relationship to ventilation and gas exchange. Circulation. 1967 Apr;35(4 Suppl):I217-25. doi: 10.1161/01.cir.35.4s1.i-217. No abstract available.
PubMed 6024032Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.
PubMed 340159
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of the Lung Compliance During Extracorporeal Circulation and Post Operative Pulmonary Complications
- ClinicalTrials.gov ID
- NCT02654600
- Acronym / sponsor ID
- COMPLI / P14-37816002/2014-A00702-45
- Conditions
- Thoracic Surgery, Cardiopulmonary Bypass
- Keywords
- cardiac surgery, thoracopulmonary compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jan 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.
the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through pulmonary blood emptying.
Detailed description
compliance is the compliance calculate when thorax is closed, the pulmonary compliance is the compliance calculated when thorax is opened After operation chest X-ray are daily done and blood samples as needed. Were recorded death, time of extubation,duration of non invasive ventilation,of Intensive Care Unit stay and of total hospital stay, troponin peak, lactates, blood gases, ionogram and count.Variations of compliance is analyzed through one factor paired Anova or Wilcoxon paired test. Decrease of compliance and respiratory complications are analyzed through binomial logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every ASA 2 or 3 patient eligible for non-complex and non-urgent cardiac surgery
Key inclusion criteria (2 listed)
- scheduled for standard aortic
- mitral or coronary surgery
Key exclusion criteria (5 listed)
- emergency operation
- no complete preoperative echocardiography
- surgery needing multiple table position changes
- unstable cardiac or respiratory condition
- difficult patient needing multiple care and/or special attention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pulmonary compliance during cardiac surgery
Time frame: intraoperative
compliance is calculated by dividing tidal volume (ml) by the difference between plateau-inspiratory pressure (mmHg) and end-expiratory pressure (mmHg) before ,during and after CBP
2 secondary outcomes
pulmonary complications including death after cardiac surgery
Time frame: 1 month
thoracopulmonary compliance during cardiac surgery
Time frame: intraoperative
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 23 May 2017.
- Background: PubMed 6024032Ellison LT, Duke JF 3rd, Ellison RG. Pulmonary compliance following open-heart surgery and its relationship to ventilation and gas exchange. Circulation. 1967 Apr;35(4 Suppl):I217-25. doi: 10.1161/01.cir.35.4s1.i-217. No abstract available.
- Background: PubMed 340159Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Cardiopulmonary Bypass, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 5 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 23 May 2017. 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 France. 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?
pulmonary compliance during cardiac surgery (time frame: intraoperative). 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 NCT02654600, 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 23 May 2017.