NCT02804997

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2017

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

1.7 years

First QC Date

June 15, 2016

Last Update Submit

September 28, 2018

Conditions

Thoracic Surgery

Keywords

non-invasive ventilationcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Quantitative evaluation by thoracic CT scan

    Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery

    3 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients 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

You may qualify if:

  • 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.

You may not qualify if:

  • Under-18 patients
  • complex cardiac surgery
  • pregnancy
  • pre-existing chronic obstructive respiratory disease (COPD \> stage II)
  • legal guardianship
  • incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Study Officials

  • Elie ZOGHEIB, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 17, 2016

Study Start

May 13, 2015

Primary Completion

January 27, 2017

Study Completion

January 27, 2017

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

FR(1)