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

This study is currently recruiting participants.
Verified October 2012 by Hôpital Louis Mourier
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier
ClinicalTrials.gov Identifier:
NCT01699880
First received: October 1, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition
Need for Intubation
Oxygenation Before and During Intubation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Hôpital Louis Mourier:

Primary Outcome Measures:
  • lowest pulse oxymetry (SpO2) during intubation [ Time Frame: from beginning of laryngoscopy to completed intubation ] [ Designated as safety issue: No ]
  • mean pulse oxymetry during intubation [ Time Frame: from beginning of laryngoscopy to completed intubation ] [ Designated as safety issue: No ]
  • pulse oxymetry after preoxygenation [ Time Frame: 3min prexoxygenation ] [ Designated as safety issue: No ]
  • pulse oxymetry after intubation [ Time Frame: at connection of the patient to the ventilator ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean pulse oxymetry [ Time Frame: one, five and thirty minutes after intubation ] [ Designated as safety issue: No ]
  • number of pulse oxymetry below 90% [ Time Frame: from laryngoscopy to 30 minutes once tracheal intubation completed ] [ Designated as safety issue: No ]
  • number of pulse oxymetry below 80% [ Time Frame: from laryngoscopy to 30 minutes once tracheal intubation completed ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • cardiac arrest [ Time Frame: during and immediately after procedure ] [ Designated as safety issue: Yes ]
  • hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg [ Time Frame: during and immediately after procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: March 2011
Groups/Cohorts
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.

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.

  Eligibility

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

ICU patients requiring tracheal intubation

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699880

Contacts
Contact: Jean-Damien Ricard, MD, PhD 33147606195 jean-damien.ricard@lmr.aphp.fr
Contact: Romain Miguel-Montanes, MD 33147606195

Locations
France
Medico-surgical ICU Recruiting
Colombes, France, 92701
Contact: Jean-Damien Ricard, MD, PhD     33147606195     jean-damien.ricard@lmr.aphp.fr    
Sub-Investigator: Romain Miguel-Montanes, MD            
Sponsors and Collaborators
Hôpital Louis Mourier
Investigators
Principal Investigator: Jean-Damien Ricard, MD, PhD Hopital Louis Mourier, AP-HP, Colombes, France
  More Information

Publications:

Responsible Party: Prof Jean-Damien RICARD, Professor of Intensive Care Medicine, assistant head of ICU, Hôpital Louis Mourier
ClinicalTrials.gov Identifier: NCT01699880     History of Changes
Other Study ID Numbers: HLM_JDR1
Study First Received: October 1, 2012
Last Updated: October 3, 2012
Health Authority: France: Ministère de l'Enseignement supérieur et de la Recherche

Keywords provided by Hôpital Louis Mourier:
tracheal intubation
preoxygenation
desaturation
 hypoxemia
oxygen therapy
high flow nasal cannula oxygen therapy

ClinicalTrials.gov processed this record on May 19, 2013