An interventional study of Protocol using end-tidal oxygen monitoring during preoxygenation before intubation in Acute Hypoxemic Respiratory Failure, sponsored by University Hospital, Grenoble. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Other
The main objective of this pilot study is to determine if our protocole using EtO2 monitoring during preoxygenation before intubation is feasible in a population of critically ill patients in acute hypoxemic respirator failure (AHRF) in Intensive Care Unit (ICU).
We hypothesize that using EtO2 monitoring during preoxygenation before intubation is feasible and safe in a population of critically ill patients in AHRF in ICU setting.
Background : acute hypoxemic respiratory failure (AHRF) is one of the most common causes of intensive care unit (ICU) admission requiring subsequent tracheal intubation for invasive mechanical ventilation. Complications related to tracheal intubation are more frequent in ICU than in operating room with an incidence reaching 20 to 50% in previous studies. Among them, severe hypoxemia and hemodynamic failure can lead to cardiac arrest. End-expiratory tidal oxygen (EtO2) monitoring during preoxygenation is routinely used during anesthesia for elective surgery but has never been evaluated in ICU setting.
Objective : to evaluate the feasibility of a protocol using EtO2 monitoring during preoxygenation before intubation of patients in AHRF in ICU.
Methods : this is an interventional, prospective, bicenter (two French tertiary teaching Hospitals ICUs), feasibility study of a protocol using EtO2 monitoring during preoxygenation before rapid sequence induction (RSI) and intubation of patients in AHRF in ICU. Eligible patients will be older than 18 years, admitted to the ICU, requiring intubation, in AHRF according to the following criteria : a respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of arterial oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03). Main exclusion criteria will be contraindications to Non Invasive Ventilation (NIV) (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min), cardiac arrest, do not intubate order, pregnancy or breastfeeding and refusal to participate. In 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring. A targeted EtO2 ≥ 90% will trigger RSI and intubation. During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded. A 100- point ponderated score elaborated by an independent expert committee based on literature and updated national guidelines (4,5) will evaluate recommendations adherence. A score ≥ 85 / 100 adjudicates a procedure matching with good practices guidelines. The primary outcome is the percentage tracheal intubation procedures performed in accordance with current good practices guidelines.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 72 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
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Exclusion Criteria:
In 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring.
Procedure: Protocol using end-tidal oxygen monitoring during preoxygenation before intubation
According to previous studies a target of EtO2 ≥ 90% is proposed to trigger RSI and intubation. If this target is judged impossible to achieve and/or there is an imperative need to interrupt the pre-oxygenation phase, the operator is free to continue the procedure according to current recommendations. Before the start of the inclusions, a training session on the use of the module will be organized with a reminder of the recommendations. During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded. The procedure will stop ten minutes after completion of the orotracheal intubation procedure (defined as inflation of the balloon,clinical and capnography control).
Percentage of tracheal intubation procedures performed in accordance with current good practices guidelines (defined by an independent expert committee score ≥ 85 / 100).
Time frame: 3 hours
Sequential hierarchical analysis of next criteria
* Rate of serious complications during procedure defined by following composite criteria : deep hypoxemia (defined by SpO2 \< 80%), hemodynamic failure (defined by mean arterial pressure \< 65 mmHg despite volume expansion or use of vasopressor), cardiac arrest, death. * Rate of moderate complications during procedure defined by composite criteria : hypoxemia (defined by 80% ≤ SpO2 \< 90%), difficult intubation (defined as two unsuccessful attempts at laryngoscopy), ventricular or supra-ventricular rhythm trouble, esophageal intubation, aspiration, dental damage.
Time frame: 3 hours
Duration of preoxygenation
Time frame: 10 minutes
Maximum EtO2 level achieved
Time frame: 10 minutes
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble