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

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. Identifier: NCT02214576
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : August 14, 2015
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

Brief Summary:
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.

Condition or disease
Acute Respiratory Distress Syndrome

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation
Study Start Date : September 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Primary Outcome Measures :
  1. Oxygen saturation [ Time Frame: 30 minutes ]
    oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation

Secondary Outcome Measures :
  1. complications [ Time Frame: 60 minutes ]
    arrhythmia, hypotension, profound desaturation, cardiac arrest

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
acute respiratory distress syndrome patients that require tracheal intubation in the ICU

Inclusion Criteria:

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

Exclusion Criteria:


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 identifier (NCT number): NCT02214576

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Medico-surgical ICU, Louis Mourier Hospital
Colombes, France, 92700
Sponsors and Collaborators
Hôpital Louis Mourier
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Principal Investigator: Jean-Damien RICARD, MD, PhD University Paris Diderot and Assistance Publique - Hôpitaux de Paris
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Responsible Party: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, Assistant-head of ICU, Hôpital Louis Mourier Identifier: NCT02214576    
Other Study ID Numbers: HLM_JDR2
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015
Keywords provided by Prof Jean-Damien RICARD, Hôpital Louis Mourier:
Respiratory Distress Syndrome, Adult
intubation, intratracheal
Oxygen Inhalation Therapy
Positive-Pressure Respiration
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury