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

Thoracic Surgery Clinical Trial

— COMPLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654600
• Other study ID #: P14-37816002/2014-A00702-45
• Status: Completed
• Phase: N/A
• First received: September 2, 2015
• Last updated: May 21, 2017
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Centre Chirurgical Marie Lannelongue
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 pulmonary blood emptying.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Thoracic Surgery

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson

Sponsors (1)

Lead Sponsor	Collaborator
Centre Chirurgical Marie Lannelongue

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Suter 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperative
Secondary	pulmonary complications including death after cardiac surgery	intersticial and/or alveolar pulmonary oedema leading to death or extra hospital stay	1 month
Secondary	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	intraoperative