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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02804997
Other study ID # PI2014_843_0020
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 13, 2015
Est. completion date January 27, 2017

Study information

Verified date September 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date January 27, 2017
Est. primary completion date January 27, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18

- in the post-operative phase after elective cardiac surgery for aortic or mitral valve replacement, coronary revascularization or mixed surgery, hypoxemia or hypercapnia, with an indication for NIV,

- hemodynamic stability

- prior consent

- spontaneous ventilation

- social security coverage.

Exclusion Criteria:

- Under-18 patients

- complex cardiac surgery

- pregnancy

- pre-existing chronic obstructive respiratory disease (COPD > stage II)

- legal guardianship

- incarceration

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative evaluation by thoracic CT scan Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery 3 hours
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