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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02654600
Other study ID # P14-37816002/2014-A00702-45
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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