Trial · NCT05267652
Pragmatic Trial Examining Oxygenation Prior to Intubation
NCT05267652, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2024-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pragmatic Trial Examining Oxygenation Prior to Intubation. Trials, record NCT05267652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05267652
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pragmatic Trial Examining Oxygenation Prior to Intubation
- NCT number
- NCT05267652
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,301 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Acute Respiratory Failure
- Interventions
- Preoxygenation with Non-Invasive Positive Pressure Ventilation, Facemask Oxygen
- First posted
- 2022-03-04
- Last updated
- 2024-12-09
- Results first posted
- 2024-12-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Hypoxemia | from induction to 2 minutes following tracheal intubation | A peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation |
| Secondary | Lowest Oxygen Saturation | from induction to 2 minutes following tracheal intubation | Lowest oxygen saturation during the interval between induction and 2 minutes after tracheal intubation |
| Other | Incidence of Operator-reported Aspiration | from induction to 2 minutes following tracheal intubation | |
| Other | Fraction of Inspired Oxygen at 24 Hours After Induction | 24 hours after induction | |
| Other | Oxygen Saturation at 24 Hours After Induction | 24 hours after induction | |
| Other | Incidence of Pneumothorax | from induction to 24 hours after induction | Radiology report of new pneumothorax on chest x-ray in the 24 hours after induction |
| Other | Incidence of New Infiltrate | from induction to 24 hours after induction | Radiology report of new infiltrate on chest imaging in the 24 hours after intubation |
| Other | Incidence of Severe Hypoxemia | from induction to 2 minutes following tracheal intubation | Lowest oxygen saturation of \<80% between induction and two minutes after tracheal intubation |
| Other | Incidence of Very Severe Hypoxemia | from induction to 2 minutes following tracheal intubation | Lowest oxygen saturation of \<70% between induction and two minutes after tracheal intubation |
| Other | Oxygen Saturation at Induction | from enrollment to induction |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Hypoxemia | from induction to 2 minutes following tracheal intubation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Lowest Oxygen Saturation | from induction to 2 minutes following tracheal intubation | Oxygen Saturation (%) | MEDIAN | |
| OTHER_PRE_SPECIFIED | Incidence of Operator-reported Aspiration | from induction to 2 minutes following tracheal intubation | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Fraction of Inspired Oxygen at 24 Hours After Induction | 24 hours after induction | Percentage | MEDIAN | |
| OTHER_PRE_SPECIFIED | Oxygen Saturation at 24 Hours After Induction | 24 hours after induction | Oxygen Saturation (%) | MEDIAN | |
| OTHER_PRE_SPECIFIED | Incidence of Pneumothorax | from induction to 24 hours after induction | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Incidence of New Infiltrate | from induction to 24 hours after induction | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Incidence of Severe Hypoxemia | from induction to 2 minutes following tracheal intubation | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Incidence of Very Severe Hypoxemia | from induction to 2 minutes following tracheal intubation | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Oxygen Saturation at Induction | from enrollment to induction | Oxygen Saturation (%) | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Hypoxemia | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 57 | Participants | ||
| Incidence of Hypoxemia | Preoxygenation With Facemask Oxygen Group | 118 | Participants | ||
| Lowest Oxygen Saturation | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 99 | Inter-Quartile Range 95 to 100 | Oxygen Saturation (%) | |
| Lowest Oxygen Saturation | Preoxygenation With Facemask Oxygen Group | 97 | Inter-Quartile Range 89 to 100 | Oxygen Saturation (%) | |
| Incidence of Operator-reported Aspiration | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 6 | Participants | ||
| Incidence of Operator-reported Aspiration | Preoxygenation With Facemask Oxygen Group | 9 | Participants | ||
| Fraction of Inspired Oxygen at 24 Hours After Induction | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 40 | Inter-Quartile Range 30 to 40 | Percentage | |
| Fraction of Inspired Oxygen at 24 Hours After Induction | Preoxygenation With Facemask Oxygen Group | 40 | Inter-Quartile Range 30 to 40 | Percentage | |
| Oxygen Saturation at 24 Hours After Induction | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 97 | Inter-Quartile Range 95 to 100 | Oxygen Saturation (%) | |
| Oxygen Saturation at 24 Hours After Induction | Preoxygenation With Facemask Oxygen Group | 97 | Inter-Quartile Range 95 to 100 | Oxygen Saturation (%) |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 645 | |
| Overall Study | STARTED | Preoxygenation With Facemask Oxygen Group | 656 | |
| Overall Study | COMPLETED | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 645 | |
| Overall Study | COMPLETED | Preoxygenation With Facemask Oxygen Group | 656 | |
| Overall Study | NOT COMPLETED | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 0 | |
| Overall Study | NOT COMPLETED | Preoxygenation With Facemask Oxygen Group | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Aspiration | Surgical and medical procedures | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 2 | 645 | 2 |
| serious | Aspiration | Surgical and medical procedures | Preoxygenation With Facemask Oxygen Group | 0 | 656 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 209 | 645 |
| Total, all-cause mortality | Preoxygenation With Facemask Oxygen Group | 217 | 656 |
| Total, other adverse events | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 0 | 645 |
| Total, other adverse events | Preoxygenation With Facemask Oxygen Group | 0 | 656 |
| Total, serious adverse events | Preoxygenation With Non-Invasive Positive Pressure Ventilation Group | 2 | 645 |
| Total, serious adverse events | Preoxygenation With Facemask Oxygen Group | 0 | 656 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Very Severe Hypoxemia | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Pneumothorax | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of New Infiltrate | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Hypoxemia | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Cardiovascular Collapse | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Severe Hypoxemia | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Successful Intubation on the First Attempt | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: 28-day In-hospital Mortality | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: deaths from any cause | Trial comparisons |
| Preoxygenation With Non-Invasive Positive Pressure Ventilation Group vs Preoxygenation With Facemask Oxygen Group: Incidence of Operator-reported Aspiration | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05267652
GET https://conductscience.org/api/trials/v1/NCT05267652/registered?page=2