Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804997
Recruitment Status : Terminated (internal recruitment difficulties and reorganization of the Intensive Care Units)
First Posted : June 17, 2016
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease
Thoracic Surgery

Layout table for study information
Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery
Actual Study Start Date : May 13, 2015
Actual Primary Completion Date : January 27, 2017
Actual Study Completion Date : January 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Quantitative evaluation by thoracic CT scan [ Time Frame: 3 hours ]
    Quantitative evaluation performed by thoracic CT scan of alveolar recruitment induced by NIV after cardiac surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804997


Locations
Layout table for location information
France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Principal Investigator: Elie ZOGHEIB, PhD CHU Amiens
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02804997    
Other Study ID Numbers: PI2014_843_0020
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
non-invasive ventilation
cardiac surgery