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

Completed

• Conditions: Cardiopulmonary Bypass; Thoracic Surgery

• Registration Number: NCT02654600
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief 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 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 Timeline

• Study Start: 2014-06
• Primary Completion: 2014-06
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-13
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-21
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pulmonary compliance during cardiac surgery	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 Outcome Measures

Name	Time	Method
thoracopulmonary compliance during cardiac surgery	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
pulmonary complications including death after cardiac surgery	1 month	intersticial and/or alveolar pulmonary oedema leading to death or extra hospital stay

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France