CHRU de Tours
Tours, 37000, France
Location contact
Amélie DELAGE
CONTACT
Mai-Anh Nay, MD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07189338
The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (HFNO) would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.
The sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:
Experimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).
non-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.
At the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
Control group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Tours, 37000, France
Amélie DELAGE
CONTACT
Mai-Anh Nay, MD
PRINCIPAL_INVESTIGATOR
CONTACT
Endotracheal intubation is often performed in intensive care unit (ICU). Severe complications (such as severe hypoxemia, hypotension, cardiac arrest) occur up to 50%. Severe hypoxemia is more frequent in patients with hypoxemia prior to intubation or during difficult intubation and could increase the risk of cardiac arrest.
The procedure of intubation includes, in order 1) a preoxygenation phase ending with iv administration of anesthetic drugs 2) a hypoventilation phase 3) an apneic phase beginning with laryngoscopy and ending with successful intubation 4) mechanical ventilation. Optimization of this procedure is essential.
Non-invasive ventilation (NIV) is recommended for preoxygenation in hypoxemic patients and this technique can maintain ventilation during the hypoventilation phase.
Apneic oxygenation is defined as the administration of oxygen during the apneic phase. The objective is to increase the duration of apnea without desaturation. In physiological studies and in the operating room, when apneic oxygen is used with standard oxygen (up to 15L/min) or high-flow nasal oxygenation (HFNO) (up to 70L/min and FiO2 at 1.0), the apnea length without desaturation can reach several minutes.
Several meta-analyses (with high heterogeneity between studies) found that apneic oxygenation (including standard oxygen or HFNO) in emergency intubation could decrease the risk of hypoxemia. In most studies that investigated the effect of HFNO as apneic oxygenation, HFNO was also used as a preoxygenation method. Thus, the different methods of preoxygenation could affect the real effect of apneic oxygenation.
Only one single-center study evaluated apneic oxygenation with HFNO after preoxygenation by NIV. In this study the lowest SpO2 during intubation procedure was significantly higher in the apneic oxygenation group. However, in this study the mask used for NIV was applied over the nasal cannulas of HFNO, which may have resulted in less efficient preoxygenation due to leakage.
Intubation rate for HFNO failure during acute respiratory failure is about 40% in ICU patients. The question of continuing HFNO or not during the apnea phase remains open. The experts suggest continuing HFNO during intubation (conditional recommendation, moderate certainty).
We hypothesized that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.
In both groups, NIV will be used during the preoxygenation and hypoventilation phases.
Procedure of intubation will be standardized according to guidelines
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After removing the facemask, the nasal cannulas of HFNO will be placed in the patient's nares then the laryngoscopy will be performed.
After removing the facemask, laryngoscopy will be performed without oxygen.
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) < 80%
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The incidence of prolonged severe hypoxemia defined by an SpO2 < 80% for more than 24 seconds
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The highest and lowest SpO2 values during the procedure
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation
The occurrence of each immediate severe complications including cardiovascular instability (systolic arterial blood pressure <65 mmHg at least once, new or increase need of vasopressors or fluid bolus >15 mL/kg), cardiac arrest, new onset cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, bradycardia <30beats per minute).
Time frame: from the start of laryngoscopy to 5 minutes after successful intubation; At Day 28
The occurrence of each other adverse events: difficult intubation (defined as a procedure requiring more than 2 laryngoscopy attempts before success), operator-reported aspiration between induction and intubation, dental injury, esophageal intubation, pneumothorax visualized on the follow-up chest X-ray as part of the patient's routine care.
Time frame: From the 1st attempt to the successful intubation
The duration of laryngoscopy will be compared in both group
Time frame: from the 1st attempt to the successful intubation
The number of laryngoscopies will be compared in both group
Time frame: at Day 28
Contact information is provided by the study sponsor or research team.
University Hospital, Tours
Other
Acronym: APNEIC
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