NCT02214576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

3.9 years

First QC Date

August 11, 2014

Last Update Submit

August 13, 2015

Conditions

Keywords

Respiratory Distress Syndrome, Adultintubation, intratrachealOxygen Inhalation TherapyPositive-Pressure Respirationlaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Oxygen saturation

    oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation

    30 minutes

Secondary Outcomes (1)

  • complications

    60 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medico-surgical ICU, Louis Mourier Hospital

Colombes, 92700, France

Location

Related Publications (4)

  • Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.

    PMID: 22531566BACKGROUND
  • Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

    PMID: 21946925BACKGROUND
  • Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.

    PMID: 21958974BACKGROUND
  • Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.

    PMID: 25371400BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jean-Damien RICARD, MD, PhD

    University Paris Diderot and Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Intensive Care Medicine, Assistant-head of ICU

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 12, 2014

Study Start

September 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations