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Completed

NCT Number: NCT01699880

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

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).

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Key information

Conditions

Need for Intubation Hypoxia Oxygenation Before and During Intubation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medico-surgical ICU

Colombes, 92701, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. lowest pulse oxymetry (SpO2) during intubation

    Time frame: from beginning of laryngoscopy to completed intubation

  2. mean pulse oxymetry during intubation

    Time frame: from beginning of laryngoscopy to completed intubation

  3. pulse oxymetry after preoxygenation

    Time frame: 3min prexoxygenation

  4. pulse oxymetry after intubation

    Time frame: at connection of the patient to the ventilator

Secondary outcomes

  1. mean pulse oxymetry

    Time frame: one, five and thirty minutes after intubation

  2. number of pulse oxymetry below 90%

    Time frame: from laryngoscopy to 30 minutes once tracheal intubation completed

  3. number of pulse oxymetry below 80%

    Time frame: from laryngoscopy to 30 minutes once tracheal intubation completed

Other outcomes

  1. cardiac arrest

    Time frame: during and immediately after procedure

  2. hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg

    Time frame: during and immediately after procedure

Sponsors and collaborators

Lead sponsor

Hôpital Louis Mourier

Other

Registry information

Official study title

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

Acronym: HAPI

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2012
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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