Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

Need for Intubation, No Severe Hypoxemia Clinical Trial

— PROTRACH  

Official title:

A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700321
• Other study ID #: RC15_0047
• Status: Completed
• Phase: N/A
• Start date: April 28, 2016
• Est. completion date: October 5, 2017

Study information

• Verified date: March 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

Description:

This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula "HFNC" or standard High Flow face mask "HFFM".

Patients randomized in "HFNC" group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation.

Patients randomized in "HFFM" group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 5, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults older than 18 years regardless of the gender

• Requiring orotracheal intubation in intensive care unit

• "No severely hypoxemic respiratory failure" defined as Oxygen Pression (Pa02)/FI02 > 200 mmHg measured in the 4 hours before inclusion

Exclusion Criteria:

• Not the first Intubation during this stay in intensive care unit

• Contraindication to oro-tracheal intubation

• Intubation without anaesthesic rapid sequence induction

• Intubation during cardiac arrest

• Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization)

• Nasopharyngeal obstacle with contraindication to use Optiflow device

• Patients with a documented Cormack IV exposition before inclusion

• Protected adult

• Pregnancy or breastfeeding

• Lack of consent

• Patient already enrolled in another study that could interfere with the primary objective of this study

Related Conditions & MeSH terms

• Hypoxia
• Need for Intubation, No Severe Hypoxemia

Intervention

Device:
• OPTIFLOW/ AIRVO
Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/AIRVO® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.

Procedure:
• STANDARD Face Mask
Patients randomized in "STANDARD Face Mask" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction.

Locations

Country	Name	City	State
France	Brest hospital, CHU La cavale Blanche, medical intensive care unit	Brest
France	CHD LES OUDOUAIRIES Service de réanimation polyvalente	La Roche Sur Yon
France	Ch Le Mans	Le Mans
France	Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit	Nantes
France	Nantes University Hospital, Hôtel Dieu, Medical intensive care unit	Nantes
France	Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit	Rennes
France	Nantes University hospital, Hôpital Laennec, pneumology intensive care unit	St Herblain
France	Tours university hospital, hôpital Bretonneau, medical intensive care unit	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lowest pulse oxymetry (SpO2) during intubation	This outcome will be assessed from the beginning of the endotracheal intubation procedure (immediately after induction) to the end of orotracheal intubation (airway catheterization) by monitoring the pulse oxymetry	From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes
Secondary	Pulse oximetry		from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
Secondary	number of desaturation events (under 80%)		From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
Secondary	Reduction in morbi-mortality during the Intensive care Unit stay		from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
Secondary	SOFA score		Each day during the 5 first days after randomisation