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OpenTrials
Completed

NCT Number: NCT02654600

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

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.

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Key information

Conditions

Thoracic Surgery Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. pulmonary complications including death after cardiac surgery

    Time frame: 1 month

    intersticial and/or alveolar pulmonary oedema leading to death or extra hospital stay

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Acronym: COMPLI

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Jan 13, 2016
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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