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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02700321
Acronym
PROTRACH
Enrollment
192
Registered
2016-03-07
Start date
2016-04-28
Completion date
2017-10-05
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Need for Intubation, No Severe Hypoxemia

Keywords

non severely hypoxemic respiratory failure, preoxygenation, crash induction

Brief 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

Detailed 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

Interventions

DEVICEOPTIFLOW/ 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.

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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
lowest pulse oxymetry (SpO2) during intubationFrom 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 minutesThis 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

Secondary

MeasureTime frame
Pulse oximetryfrom the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
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)
Reduction in morbi-mortality during the Intensive care Unit stayfrom beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
SOFA scoreEach day during the 5 first days after randomisation

Countries

France

Contacts

PRINCIPAL_INVESTIGATOROlivier ZAMBON, MD

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026