N/A
Completed N=1,301
Pragmatic Trial Examining Oxygenation Prior to Intubation
Source: ClinicalTrials.gov NCT05267652 ↗Enrolled (actual)
1,301
Serious AEs
0.2%
Results posted
Dec 2024
Primary outcomePrimary: Incidence of Hypoxemia — 57; 118 Participants
Summary
Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. One-in-ten emergency tracheal intubations is complicated by life-threatening hypoxemia. Administering supplemental oxygen prior to induction and intubation ("preoxygenation") decreases the risk of life-threatening hypoxemia. In current clinical practice, the most common methods for preoxygenation are non-invasive positive pressure ventilation and facemask oxygen. Prior trials comparing non-invasive positive pressure ventilation and facemask oxygen for preoxygenation have been small and have yielded conflicting results. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to preoxygenation could improve the care clinicians deliver and patient outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hypoxemia |
57; 118 | — |
| SECONDARY Lowest Oxygen Saturation |
99; 97 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is located in a participating unit
- Planned procedure is tracheal intubation using a laryngoscope and sedation
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.
Exclusion Criteria
- Patient is receiving positive pressure ventilation by a mechanical ventilator, bag-mask device, or laryngeal mask airway
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Immediate need for tracheal intubation precludes safe performance of study procedures
- Patient is apneic, hypopneic, or has another condition requiring positive pressure ventilation between enrollment and induction
- Operator has determined that preoxygenation with non-invasive positive pressure ventilation or preoxygenation with a facemask is required or contraindicated for optimal care of the patient
Data sourced from ClinicalTrials.gov (NCT05267652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.