CClinicalTrials.gg
TerminatedNCT02804997ARCTICSUpdated Oct 1, 2018

Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

An observational study in Thoracic Surgery, sponsored by Centre Hospitalier Universitaire, Amiens. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-01.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Why this study was terminated
internal recruitment difficulties and reorganization of the Intensive Care Units
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thoracic Surgery

Keywords

  • non-invasive ventilation
  • cardiac surgery
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

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

Exclusion Criteria:

  • Under-18 patients
  • complex cardiac surgery
  • pregnancy
  • pre-existing chronic obstructive respiratory disease (COPD > stage II)
  • legal guardianship
  • incarceration
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No
06

What researchers measure

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

    Time frame: 3 hours

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02804997
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 17, 2016
Start date
May 13, 2015
Primary completion
Jan 27, 2017
Completion
Jan 27, 2017
Last update
Oct 1, 2018

Study contacts

Elie ZOGHEIB, PhD
principal investigator · CHU Amiens
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion