Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01699880
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Prof Jean-Damien RICARD, Hôpital Louis Mourier

Tracking Information
First Submitted Date October 1, 2012
First Posted Date October 4, 2012
Last Update Posted Date August 12, 2014
Study Start Date March 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2012)
  • lowest pulse oxymetry (SpO2) during intubation [ Time Frame: from beginning of laryngoscopy to completed intubation ]
  • mean pulse oxymetry during intubation [ Time Frame: from beginning of laryngoscopy to completed intubation ]
  • pulse oxymetry after preoxygenation [ Time Frame: 3min prexoxygenation ]
  • pulse oxymetry after intubation [ Time Frame: at connection of the patient to the ventilator ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 3, 2012)
  • mean pulse oxymetry [ Time Frame: one, five and thirty minutes after intubation ]
  • number of pulse oxymetry below 90% [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 3, 2012)
  • cardiac arrest [ Time Frame: during and immediately after procedure ]
  • hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg [ Time Frame: during and immediately after procedure ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation
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
Brief Summary 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).
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ICU patients requiring tracheal intubation
Condition
  • Need for Intubation
  • Oxygenation Before and During Intubation
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 11, 2014)
101
Original Estimated Enrollment
 (submitted: October 3, 2012)
90
Actual Study Completion Date January 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01699880
Other Study ID Numbers HLM_JDR1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof Jean-Damien RICARD, Hôpital Louis Mourier
Study Sponsor Hôpital Louis Mourier
Collaborators Not Provided
Investigators
Principal Investigator: Jean-Damien Ricard, MD, PhD Hopital Louis Mourier, AP-HP, Colombes, France
PRS Account Hôpital Louis Mourier
Verification Date August 2014