High Flow Nasal Canula Oxygen Helps Preoxygenate ARDS Patients (HIGHER)

August 13, 2015 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation

Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.

Study Overview

Status

Completed

Conditions

Detailed Description

High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in patients with acute respiratory failure. One of the major advantages of high flow nasal canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby providing high flow apneic oxygenation. In addition, and contrary no non-invasive ventilation, preoxygenation may be used in patients with neurological impairment. Finally, the interest of this device is that it is the same that is maintained throughout the whole management of the patient, from ICU admission to intubation.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Medico-surgical ICU, Louis Mourier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

acute respiratory distress syndrome patients that require tracheal intubation in the ICU

Description

Inclusion Criteria:

  • ARDS according to the Berlin criteria
  • use of high flow nasal canula oxygen

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: 30 minutes
oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 60 minutes
arrhythmia, hypotension, profound desaturation, cardiac arrest
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Louis Mourier

Investigators

  • Principal Investigator: Jean-Damien RICARD, MD, PhD, University Paris Diderot and Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLM_JDR2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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