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Pragmatic Trial Examining Oxygenation Prior to Intubation
NA trial testing Preoxygenation with Non-Invasive Positive Pressure Ventilation in Acute Respiratory Failure in 1,301 participants. Completed in 11 November 2023.
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,301 |
| Start date | 10 March 2022 |
| Primary completion | 14 October 2023 |
| Estimated completion | 11 November 2023 |
| Sites | 16 locations across United States |
Vanderbilt University Medical Center
18 and older, any sex, with Acute Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 57 | |
| Preoxygenation With Facemask Oxygen Group | 118 |
Lowest oxygen saturation during the interval between induction and 2 minutes after tracheal intubation
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 99 | 95 – 100 |
| Preoxygenation With Facemask Oxygen Group | 97 | 89 – 100 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 6 | |
| Preoxygenation With Facemask Oxygen Group | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 40 | 30 – 40 |
| Preoxygenation With Facemask Oxygen Group | 40 | 30 – 40 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 97 | 95 – 100 |
| Preoxygenation With Facemask Oxygen Group | 97 | 95 – 100 |
Radiology report of new pneumothorax on chest x-ray in the 24 hours after induction
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 7 | |
| Preoxygenation With Facemask Oxygen Group | 7 |
Radiology report of new infiltrate on chest imaging in the 24 hours after intubation
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 144 | |
| Preoxygenation With Facemask Oxygen Group | 148 |
Lowest oxygen saturation of \<80% between induction and two minutes after tracheal intubation
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 39 | |
| Preoxygenation With Facemask Oxygen Group | 84 |
Lowest oxygen saturation of \<70% between induction and two minutes after tracheal intubation
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 15 | |
| Preoxygenation With Facemask Oxygen Group | 36 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 100 | 99 – 100 |
| Preoxygenation With Facemask Oxygen Group | 100 | 97 – 100 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 124 | 107 – 143 |
| Preoxygenation With Facemask Oxygen Group | 129 | 111 – 148 |
| Group | Value | 95% CI |
|---|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 115 | 89 – 150 |
| Preoxygenation With Facemask Oxygen Group | 113 | 85 – 152 |
Time frame: Adverse events were collected from enrollment to 28 days after enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Preoxygenation With Non-In… | Preoxygenation With Facema… |
|---|---|---|---|
| Aspiration | Surgical and medical procedures | — | — |
Most-reported serious reactions: Aspiration.
Data from ClinicalTrials.gov NCT05267652 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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