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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hôpital Louis Mourier
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier
ClinicalTrials.gov Identifier:
NCT02214576
First received: August 11, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation

Resource links provided by NLM:


Further study details as provided by Hôpital Louis Mourier:

Primary Outcome Measures:
  • Oxygen saturation [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation


Secondary Outcome Measures:
  • complications [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
    arrhythmia, hypotension, profound desaturation, cardiac arrest


Estimated Enrollment: 45
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02214576

Contacts
Contact: Jean-Damien RICARD, MD, PhD +33147606195 jean-damien.ricard@lmr.aphp.fr

Locations
France
Medico-surgical ICU, Louis Mourier Hospital Recruiting
Colombes, France, 92700
Sub-Investigator: Karim BEN AHMED, MD         
Sub-Investigator: Romain MIGUEL MONTANES, MD         
Sub-Investigator: Jonathan MESSIKA, MD         
Sponsors and Collaborators
Hôpital Louis Mourier
Investigators
Principal Investigator: Jean-Damien RICARD, MD, PhD University Paris Diderot and Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, Assistant-head of ICU, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT02214576     History of Changes
Other Study ID Numbers: HLM_JDR2
Study First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche
France: Ministry of Health

Keywords provided by Hôpital Louis Mourier:
Respiratory Distress Syndrome, Adult
intubation, intratracheal
Oxygen Inhalation Therapy
Positive-Pressure Respiration
laryngoscopy

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014