Trial Outcomes & Findings for Hypoxemia in the First 24 Hours After Trauma

Results Overview

The primary outcome of the study was the occurrence and distribution of clinically relevant hypoxemic episodes, assessed asincidence rates (IRs) of episodes during daytime (08:00-19:59) and nighttime (20:00-07:59) within the first 24 h of hospitalization following trauma. No universally accepted definition of hypoxemic episodes exists. In this study we defined a clinically relevant hypoxemic episode as SpO2 \< 90%, for \> 5 min.

Recruitment status

COMPLETED

Target enrollment

165 participants

Primary outcome timeframe

24 hours

Results posted on

2026-04-21

Participant Flow

All trauma patients admitted to the trauma centre at Rigshospitalet, Denmark, during the study period were screened for inclusion, with formal inclusion determined by the trauma team leader. From February 20, 2024, to March 6, 2024, inclusion was limited to weekday day shifts (07:45-15:00). From March 7, 2024, to April 14, 2024, it was extended to 24 h coverage on weekdays. From April 15, 2024, to August 24, 2024, inclusion was further expanded to 24 h coverage 7 days a week.

Data from 155 participants were analyzed. Data collection failed on nine occasions, and one participant did not consent.

Participant milestones

Participant milestones
Measure	Included Participants Continuous pulse oximetry was used to measure SpO2 with the Nellcor Portable SpO2 Patient Monitoring System, PM10N (Medtronic, Minneapolis, USA), placed on the participants´ index finger or alternatively on another finger or toe if neces- sary. The Nellcor Flexible SpO2 Reusable Sensor was primarily used, in a few cases the Nellcor adhesive SpO2 sensor was used instead. Recording was continuous (every second), with the use of project specific equipment in addition to the clinically used standard monitoring, aiming for 24 uninterrupted hours.
Overall Study STARTED	165
Overall Study Participants with daytime measurements	154
Overall Study Participants with nighttime measurements	136
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Included Participants Continuous pulse oximetry was used to measure SpO2 with the Nellcor Portable SpO2 Patient Monitoring System, PM10N (Medtronic, Minneapolis, USA), placed on the participants´ index finger or alternatively on another finger or toe if neces- sary. The Nellcor Flexible SpO2 Reusable Sensor was primarily used, in a few cases the Nellcor adhesive SpO2 sensor was used instead. Recording was continuous (every second), with the use of project specific equipment in addition to the clinically used standard monitoring, aiming for 24 uninterrupted hours.
Overall Study Failed data collection	9
Overall Study Did not consent to participation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Included Participants n=155 Participants Continuous pulse oximetry was used to measure SpO2 with the Nellcor Portable SpO2 Patient Monitoring System, PM10N (Medtronic, Minneapolis, USA), placed on the participants´ index finger or alternatively on another finger or toe if neces- sary. The Nellcor Flexible SpO2 Reusable Sensor was primarily used, in a few cases the Nellcor adhesive SpO2 sensor was used instead. Recording was continuous (every second), with the use of project specific equipment in addition to the clinically used standard monitoring, aiming for 24 uninterrupted hours.
Age, Continuous	49 Years n=155 Participants
Sex: Female, Male Female	39 Participants n=155 Participants
Sex: Female, Male Male	116 Participants n=155 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Of the 155 included participants, 154 had at least one daytime measurement of SpO2, while 136 had at least one nighttime measurement.

The primary outcome of the study was the occurrence and distribution of clinically relevant hypoxemic episodes, assessed asincidence rates (IRs) of episodes during daytime (08:00-19:59) and nighttime (20:00-07:59) within the first 24 h of hospitalization following trauma. No universally accepted definition of hypoxemic episodes exists. In this study we defined a clinically relevant hypoxemic episode as SpO2 \< 90%, for \> 5 min.

Outcome measures

Outcome measures
Measure	Daytime n=154 Participants Participants, that had at least one daytime measurement of SpO2, corresponding to one second of measurement	Nighttime n=136 Participants Participants, that had at least one nighttime measurement of SpO2, corresponding to one second of measurement.
Occurrence of Hypoxemia	5.1 IR of episodes pr. 100 participant-hours	5.1 IR of episodes pr. 100 participant-hours

SECONDARY outcome

Timeframe: 24 hours

IRs of hypoxemic episodes across different hospital locations, including the trauma center, ICU, operating room, recovery room, and ward.

Outcome measures

Outcome measures
Measure	Daytime n=154 Participants Participants, that had at least one daytime measurement of SpO2, corresponding to one second of measurement	Nighttime n=136 Participants Participants, that had at least one nighttime measurement of SpO2, corresponding to one second of measurement.
Location of Hypoxemia (Specific Departments) Intensive Care Unit	3.3 IR of episodes pr. 100 participant-hours	2.4 IR of episodes pr. 100 participant-hours
Location of Hypoxemia (Specific Departments) Trauma Center	6.7 IR of episodes pr. 100 participant-hours	4.5 IR of episodes pr. 100 participant-hours
Location of Hypoxemia (Specific Departments) Ward	6.4 IR of episodes pr. 100 participant-hours	8.5 IR of episodes pr. 100 participant-hours
Location of Hypoxemia (Specific Departments) Operating Room	6.6 IR of episodes pr. 100 participant-hours	0 IR of episodes pr. 100 participant-hours
Location of Hypoxemia (Specific Departments) Recovery Room	0 IR of episodes pr. 100 participant-hours	0 IR of episodes pr. 100 participant-hours

SECONDARY outcome

Timeframe: 24 hours

IRs of prolonged hypoxemic episodes (SpO2 \< 90%, for \> 30 min)

Outcome measures

Outcome measures
Measure	Daytime n=154 Participants Participants, that had at least one daytime measurement of SpO2, corresponding to one second of measurement	Nighttime n=136 Participants Participants, that had at least one nighttime measurement of SpO2, corresponding to one second of measurement.
Prolonged Hypoxemic Episodes	0.9 IR of episodes pr. 100 participant-hours	1.0 IR of episodes pr. 100 participant-hours

SECONDARY outcome

Timeframe: 24 hours

Cumulative duration of hypoxemia (total time with SpO2 \< 90%).

Outcome measures

Outcome measures
Measure	Daytime n=154 Participants Participants, that had at least one daytime measurement of SpO2, corresponding to one second of measurement	Nighttime n=136 Participants Participants, that had at least one nighttime measurement of SpO2, corresponding to one second of measurement.
Cumulated Time of Hypoxemia	5.5 Minutes of SpO2 < 90% Interval 0.7 to 19.4	3.0 Minutes of SpO2 < 90% Interval 0.2 to 12.7

Adverse Events

Included Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Jensen-Abbew

Department of Anaesthesiology, Centre of Head and Orthopaedics, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark

Phone: +4528733522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place