Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation (HAPI)

August 11, 2014 updated by: Prof Jean-Damien RICARD, Hôpital Louis Mourier

High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks

Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

Study Overview

Status

Completed

Conditions

Detailed Description

Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic respiratory failure. A nasal catheter is positioned to ensure a low oxygen flow during laryngoscopy. Whether or not all patients should benefit from high flow nasal cannula oxygen therapy for pre-oxygenation remains unknown. In order to improve quality of care delivered to our patients and in anticipation of a change in our practice, we decided to record prospectively oxygen parameters during and immediately of intubation using a facemask and to compare them with parameters obtained in patients intubated after our change in practice. The change of practice consists in the systematic use of high flow nasal cannula oxygen therapy to ensure pre and during procedure (tracheal intubation)oxygenation.

Study Type

Observational

Enrollment (Actual)

101

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, 92701
        • Medico-surgical ICU

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

ICU patients requiring tracheal intubation

Description

Inclusion Criteria:

  • ICU patient requiring tracheal intubation

Exclusion Criteria:

  • age < 18 years
  • cardiac arrest
  • acute respiratory failure requiring immediate high flow nasal cannula oxygen, defined as patient with SpO2 < 95% while under 15 L:min oxygen with a nonrebreathing facemask

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

Cohorts and Interventions

Group / Cohort
conventional high FiO2 bag reservoir facemask
this group of patients is intubated according to our current practice that requires the use of a high FiO2 nonrebreathing with bag reservoir facemask to ensure preoxygenation in patients requiring tracheal intubation. a small nasal catheter is inserted just before laryngoscopy to ensure a low oxygen flow to allow oxygenation during laryngoscopy.
high flow nasal cannula oxygen
we wish to change our standard practice of preoxygenation and expand our use of high flow nasal cannula oxygen therapy to the tracheal intubation setting. Currently, used of high flow oxygen nasal cannula oxygen therapy to ensure oxygenation during intubation is limited to the patients already under high flow nasal cannula oxygen. the change of practice consists in the systematic use of high flow nasal cannula oxygen therapy in all patients requiring tracheal intubation in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lowest pulse oxymetry (SpO2) during intubation
Time Frame: from beginning of laryngoscopy to completed intubation
from beginning of laryngoscopy to completed intubation
mean pulse oxymetry during intubation
Time Frame: from beginning of laryngoscopy to completed intubation
from beginning of laryngoscopy to completed intubation
pulse oxymetry after preoxygenation
Time Frame: 3min prexoxygenation
3min prexoxygenation
pulse oxymetry after intubation
Time Frame: at connection of the patient to the ventilator
at connection of the patient to the ventilator

Secondary Outcome Measures

Outcome Measure
Time Frame
mean pulse oxymetry
Time Frame: one, five and thirty minutes after intubation
one, five and thirty minutes after intubation
number of pulse oxymetry below 90%
Time Frame: from laryngoscopy to 30 minutes once tracheal intubation completed
from laryngoscopy to 30 minutes once tracheal intubation completed
number of pulse oxymetry below 80%
Time Frame: from laryngoscopy to 30 minutes once tracheal intubation completed
from laryngoscopy to 30 minutes once tracheal intubation completed

Other Outcome Measures

Outcome Measure
Time Frame
cardiac arrest
Time Frame: during and immediately after procedure
during and immediately after procedure
hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg
Time Frame: during and immediately after procedure
during and immediately after procedure

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, Hopital Louis Mourier, AP-HP, Colombes, France

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

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HLM_JDR1

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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