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Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study

A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01747109
Acronym
PREOXYFLOW
Enrollment
122
Registered
2012-12-11
Start date
2012-11-30
Completion date
2013-08-31
Last updated
2013-12-10

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

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

Acute hypoxemic respiratory failure, Preoxygenation, Crash induction

Brief summary

Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

Detailed description

This study will be designed as followed : Patients will be randomized in 2 groups :PREOXYFLOW or STANDARD FACE MASK. Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (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 standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Interventions

DEVICEPREOXYFLOW

Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (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. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)

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 * Acute hypoxemic respiratory failure defined as : Respiratory rate \> 30/mn AND Hypoxemia with SpO2 \<90% with oxygen supply \> FiO2 0,5 AND PaO2/FiO2 \<300 mmHg

Exclusion criteria

* Contraindication to oro-tracheal intubation * Intubation without anesthetic delivery * Intubation during cardiac arrest * Asphyxia with immediate intubation needed * Nasopharyngeal obstacle with contraindication to use Optiflow device * Patients with a documented Cormack IV exposition before inclusion * Protected adult * Pregnancy * Lack of consent * Patient already enrolled in an other randomized study.

Design outcomes

Primary

MeasureTime frameDescription
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.4 minutesThis outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry

Secondary

MeasureTime frame
Improvement of quality of preoxygenation4 minutes
Reduction in side effects incidence related to intubation1 hour
Reduction in Organ failure in the 5th dayat day 5
Reduction in morbi-mortality during the Intensive Care Unit stay.until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026