Variations of the Lung Compliance During Extracorporeal Circulation and Post Operative Pulmonary Complications (COMPLI)

May 21, 2017 updated by: Centre Chirurgical Marie Lannelongue
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Plessis Robinson, France, 92350
        • Centre Chirurgical Marie Lannelongue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Every ASA 2 or 3 patient eligible for non-complex and non-urgent cardiac surgery

Description

Inclusion Criteria:

  • scheduled for standard aortic
  • mitral or coronary surgery

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary complications including death after cardiac surgery
Time Frame: 1 month
intersticial and/or alveolar pulmonary oedema leading to death or extra hospital stay
1 month
thoracopulmonary compliance during cardiac surgery
Time Frame: intraoperative
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
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Chirurgical Marie Lannelongue

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 21, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P14-37816002/2014-A00702-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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