PREOPTI-DAM
Trial question
What is the role of high-flow oxygen therapy in anticipated difficult airway management?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 185
185 patients (46 female, 139 male)
Inclusion criteria: patients with one major or two minor criteria of anticipated difficult airway management, and requiring intubation for scheduled surgery
Key exclusion criteria: hemodynamic instability; protected adult; pregnancy; enrollment in another study assessing preoxygenation device, BMI > 35 kg/m²; pulse oximetry < 90% in ambient air
Interventions
N=95 high-flow nasal cannulae (FiO2 100% and flow rate of 60 L/min for 4 minutes preoxygenation)
N=90 facemask (FiO2 100% and flow rate of 15 L/min for 4 minutes preoxygenation)
Primary outcome
Oxygen desaturation ≤ 94% or bag-mask ventilation during intubation
2
8
8.0 %
6.0 %
4.0 %
2.0 %
0.0 %
High-flow nasal
cannulae
Facemask
No significant
difference ↔
No significant difference in oxygen desaturation ≤ 94% or bag-mask ventilation during intubation (2% vs. 8%; ARD -5.6, 95% CI -11.8 to 0.6)
Secondary outcomes
Significant increase in good or excellent intubation experience (80% vs. 59%; AD 20.5%, 95% CI 8.3 to 32.8)
No significant difference in mean oxygen saturation at the end of preoxygenation (0.2% vs. 0.4%; AD 0.05%, 95% CI -0.04 to 0.14)
No significant difference in desaturation < 90% (1% vs. 2%; ARD -1.2, 95% CI -4.8 to 2.5)
Safety outcomes
No significant difference in at least one moderate or severe complication.
Conclusion
In patients with one major or two minor criteria of anticipated difficult airway management, and requiring intubation for scheduled surgery, high-flow nasal cannulae was not superior to facemask with respect to oxygen desaturation ≤ 94% or bag-mask ventilation during intubation.
Reference
Mickael Vourc'h, Donatien Huard, Marguerite Le Penndu et al. High-flow oxygen therapy versus facemask preoxygenation in anticipated difficult airway management (PREOPTI-DAM): an open-label, single-centre, randomised controlled phase 3 trial. EClinicalMedicine. 2023 May 22;60:101998.
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