TraumaHYPOX24NCT06256692
Hypoxemia in the First 24 Hours After Trauma - an Observational Study
An observational study of Trauma and Trauma Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal of this observational study is to investigate the occurrence of hypoxemia (an abnormally low concentration of oxygen in the blood) in trauma patients within the first 24 hours of hospital admission following arrival to a trauma center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Trauma Injury, Hypoxemia
- What is being tested?
- Pulse oximeter
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2024to 5 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with trauma team activation in the trauma bay at Rigshospitalet, including both direct transport and secondary transfers, will be screened for potential inclusion in the study. Patients will be included if they comply with the above eligibility criteria
Who may be able to join
- Patients aged ≥18 years
- Blunt or penetrating mechanism of trauma
- Trauma team activation
- Admission to a ward/ICU from trauma centre
Who cannot join
- Patients with a suspicion of carbon monoxide intoxication
- No applicable finger or toe for sensor attachment
- Trauma team activation was cancelled
- No available pulse oximeter at admission
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to investigate the occurrence of hypoxemia (an abnormally low concentration of oxygen in the blood) in trauma patients within the first 24 hours of hospital admission following arrival to a trauma center.
The main questions the study aims to answer are:
Read more
- Do trauma patients experience hypoxemia during the initial 24 hours of hospital admission following trauma?
- What is the daily distribution of potential hypoxemic episodes?
The investigators expect that hypoxemic episodes will be more frequent during the night (20.00-07.59) than during the day (08.00-19.59)
An additional pulse oximeter will be attached to the participants, which measures oxygen saturation in the blood during the first 24 hours of hospital admission after trauma.
Read the detailed description
Trauma is one of the leading causes of death and disability on a global scale. Advanced Trauma Life Support guidelines state serious concern with the appearance of hypoxemia after trauma, and consequently recommend that supplemental oxygen should be provided for all severely injured trauma patients to avoid hypoxemia in the initial phase. Oxygen is a vital part of human physiology and must be delivered to all metabolically active cells in the body. When patients receive supplemental oxygen, a series of autoregulatory mechanisms happen to ensure optimal oxygen levels and prevent hypoxemia and hyperoxemia which can have different harmful effects. The lack of oxygen resulting in hypoxemia can potentially be a reversible cause of poor outcomes and in worst case death, hence supplemental oxygen is recommended for trauma patients, although the evidence is sparse.
In other high-risk patient groups, such as surgical and chronic obstructive pulmonary disease (COPD) patients, a study monitored arterial oxygen saturation (SpO2) continuously and found that cumulative duration of desaturations with SpO2 < 85% was significantly associated with myocardial injury after both surgery and exacerbation of COPD. In stroke patients, a study found a higher mortality in patients that experienced hypoxemia, but after adjusting for National Institute of Health Stroke Scale and age, this association was not significant. In the study, hypoxemia was found at all stages during admission. Using continuous monitoring for 48 hours a study found that hypoxemia was common and prolonged in patients recovering from noncardiac surgery. Furthermore, this study showed that 90% of hypoxemic episodes SpO2 < 90% for at least one hour went undetected by standard spot checks, which were typically conducted at intervals of 4-6 hours.
Trauma patients can also be characterized as high-risk patients due to a high mortality. The incidence of prehospital hypoxemia in traumatic brain injury patients has been studied, a study found a prevalence of 37.9%,11 and another study discovered that prehospital hypoxemia was associated with higher mortality. Evidence about the incidence of hypoxemia in trauma patients after admission to a hospital is not well established. There is reason to suspect that trauma patients can experience episodes of hypoxemia after admission and that the incidence of hypoxemia may differ between day and night as shown in several other patient populations. Potential incidences of severe hypoxemia, from patients being admitted to a trauma centre to subsequent care in a ward, should be avoided, since severe hypoxemia is associated with harmful effects. Hypoxemia can be detected and potentially corrected with more advanced measuring equipment. It is relevant to conduct a study with the purpose of determining the occurrence and distribution over the first 24 hours after hospital admission of hypoxemia by continuous SpO2 monitoring in trauma patients, since this could potentially have important clinical implications and be useful in improving patient outcomes.
This study is a single centre study of trauma patients at Rigshospitalet, Denmark. Rigshospitalet holds the only major trauma centre in the eastern part of Denmark, and every year around 1000 trauma patients are treated here. Patients are admitted from the Capital Region of Denmark with around 1.9 million inhabitants and the Region of Zealand with around 850.000 inhabitants.
All patients with trauma team activation in the trauma bay at Rigshospitalet, including both direct transport and secondary transfers, will be screened for potential inclusion in the study.
The trauma bay at Rigshospitalet will be equipped with the oximetry equipment, and measurement can be started as early as possible. At the trauma bay, a doctor will conduct the screening and inclusion of patients to the study at arrival. After study inclusion, monitoring equipment will be attached by a nurse in the trauma bay. Subsequently a member of the study investigator group will obtain consent.
Continuous pulse oximetry will be used to measure SpO2. SpO2, heart rate, pulse amplitude and alarm status will be measured every second during a 24-hour period on all study participants.
The Nellcor™ Portable SpO2 Patient Monitoring System, PM10N (Medtronic, 15 Hampshire Street, Mansfield, MA 02048, USA) is used as monitoring device. The Covidien Nellcor FLEXMAX or a similar probe will be placed on the patients' index finger, alternatively another finger or toe.
Data collection will continue for up to 24 hours. If there is an untimely removal of the probe, the device will switch of, and data collection will stop at this point, unless the device is turned on again. After 24 hours of measurement, an investigator will collect the device and transfer the data by USB cable to a computer for secure storage and further analysis.
- Conditions
- Trauma, Trauma Injury, Hypoxemia, Hypoxia, Oxygen Deficiency
- Being tested
- Pulse oximeter
- Medical subject headings
- Wounds and Injuries, Accidental Injuries, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximeterOther
No real intervention, but all study participants will have an additional pulse oximeter attached, to measure oxygen saturation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Hypoxemia
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.
Measured: 24 hours
Secondary outcomes (3)
Location of Hypoxemia (Specific Departments)
IRs of hypoxemic episodes across different hospital locations, including the trauma center, ICU, operating room, recovery room, and ward.
Measured: 24 hours
Prolonged Hypoxemic Episodes
IRs of prolonged hypoxemic episodes (SpO2 < 90%, for > 30 min)
Measured: 24 hours
Cumulated Time of Hypoxemia
Cumulative duration of hypoxemia (total time with SpO2 < 90%).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start20 Feb 2024
- Primary completion24 Aug 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Association's Research Fund
- Responsible party
- Principal investigator, Jacob Steinmetz, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jacob Steinmetz, MD,professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256692
- Sponsor's protocol ID
- p-2023-15008
- Other IDs
- H-23065206
- Acronym
- HYPOX24
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2024
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zulazmi NA, Arulsamy A, Ali I, Zainal Abidin SA, Othman I, Shaikh MF. The utilization of small non-mammals in traumatic brain injury research: A systematic review. CNS Neurosci Ther. 2021 Apr;27(4):381-402. doi: 10.1111/cns.13590. Epub 2021 Feb 4.
PubMed 33539662ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.
PubMed 23609291Rhodes CE, Denault D, Varacallo MA. Physiology, Oxygen Transport. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538336/
PubMed 30855920Lopez-Barneo J, Ortega-Saenz P, Gonzalez-Rodriguez P, Fernandez-Aguera MC, Macias D, Pardal R, Gao L. Oxygen-sensing by arterial chemoreceptors: Mechanisms and medical translation. Mol Aspects Med. 2016 Feb-Mar;47-48:90-108. doi: 10.1016/j.mam.2015.12.002. Epub 2015 Dec 18.
PubMed 26709054Singer M, Young PJ, Laffey JG, Asfar P, Taccone FS, Skrifvars MB, Meyhoff CS, Radermacher P. Dangers of hyperoxia. Crit Care. 2021 Dec 19;25(1):440. doi: 10.1186/s13054-021-03815-y.
PubMed 34924022Eskesen TG, Baekgaard JS, Steinmetz J, Rasmussen LS. Initial use of supplementary oxygen for trauma patients: a systematic review. BMJ Open. 2018 Jul 6;8(7):e020880. doi: 10.1136/bmjopen-2017-020880.
PubMed 29982208Loft FC, Rasmussen SM, Elvekjaer M, Haahr-Raunkjaer C, Sorensen HBD, Aasvang EK, Meyhoff CS; WARD-Project Group. Continuously monitored vital signs for detection of myocardial injury in high-risk patients - An observational study. Acta Anaesthesiol Scand. 2022 Jul;66(6):674-683. doi: 10.1111/aas.14056. Epub 2022 Mar 14.
PubMed 35247272Rowat AM, Dennis MS, Wardlaw JM. Hypoxaemia in acute stroke is frequent and worsens outcome. Cerebrovasc Dis. 2006;21(3):166-72. doi: 10.1159/000090528. Epub 2005 Dec 23.
PubMed 16388191Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
PubMed 26287299Murdock D. Trauma: when there's no time to count. AORN J. 2008 Feb;87(2):322-8. doi: 10.1016/j.aorn.2007.07.008.
PubMed 18323023Stassen W, Welzel T. The prevalence of hypotension and hypoxaemia in blunt traumatic brain injury in the prehospital setting of Johannesburg, South Africa: A retrospective chart review. S Afr Med J. 2014 May 12;104(6):424-7. doi: 10.7196/samj.7494.
PubMed 25214252Chi JH, Knudson MM, Vassar MJ, McCarthy MC, Shapiro MB, Mallet S, Holcroft JJ, Moncrief H, Noble J, Wisner D, Kaups KL, Bennick LD, Manley GT. Prehospital hypoxia affects outcome in patients with traumatic brain injury: a prospective multicenter study. J Trauma. 2006 Nov;61(5):1134-41. doi: 10.1097/01.ta.0000196644.64653.d8.
PubMed 17099519Ali K, Cheek E, Sills S, Crome P, Roffe C. Day-night differences in oxygen saturation and the frequency of desaturations in the first 24 hours in patients with acute stroke. J Stroke Cerebrovasc Dis. 2007 Nov-Dec;16(6):239-44. doi: 10.1016/j.jstrokecerebrovasdis.2007.07.004.
PubMed 18035240Fanfulla F, Grassi M, Taurino AE, D'Artavilla Lupo N, Trentin R. The relationship of daytime hypoxemia and nocturnal hypoxia in obstructive sleep apnea syndrome. Sleep. 2008 Feb;31(2):249-55. doi: 10.1093/sleep/31.2.249.
PubMed 18274273Galatius-Jensen S, Hansen J, Rasmussen V, Bildsoe J, Therboe M, Rosenberg J. Nocturnal hypoxaemia after myocardial infarction: association with nocturnal myocardial ischaemia and arrhythmias. Br Heart J. 1994 Jul;72(1):23-30. doi: 10.1136/hrt.72.1.23.
PubMed 8068464
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxemia in the First 24 Hours After Trauma - an Observational Study
- ClinicalTrials.gov ID
- NCT06256692
- Acronym / sponsor ID
- HYPOX24 / p-2023-15008
- Conditions
- Trauma, Trauma Injury, Hypoxemia, Hypoxia, Oxygen Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Danish Medical Association's Research Fund
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the occurrence of hypoxemia (an abnormally low concentration of oxygen in the blood) in trauma patients within the first 24 hours of hospital admission following arrival to a trauma center.
The main questions the study aims to answer are:
- Do trauma patients experience hypoxemia during the initial 24 hours of hospital admission following trauma?
- What is the daily distribution of potential hypoxemic episodes?
The investigators expect that hypoxemic episodes will be more frequent during the night (20.00-07.59) than during the day (08.00-19.59)
An additional pulse oximeter will be attached to the participants, which measures oxygen saturation in the blood during the first 24 hours of hospital admission after trauma.
Detailed description
Trauma is one of the leading causes of death and disability on a global scale. Advanced Trauma Life Support guidelines state serious concern with the appearance of hypoxemia after trauma, and consequently recommend that supplemental oxygen should be provided for all severely injured trauma patients to avoid hypoxemia in the initial phase. Oxygen is a vital part of human physiology and must be delivered to all metabolically active cells in the body. When patients receive supplemental oxygen, a series of autoregulatory mechanisms happen to ensure optimal oxygen levels and prevent hypoxemia and hyperoxemia which can have different harmful effects. The lack of oxygen resulting in hypoxemia can potentially be a reversible cause of poor outcomes and in worst case death, hence supplemental oxygen is recommended for trauma patients, although the evidence is sparse.
In other high-risk patient groups, such as surgical and chronic obstructive pulmonary disease (COPD) patients, a study monitored arterial oxygen saturation (SpO2) continuously and found that cumulative duration of desaturations with SpO2 < 85% was significantly associated with myocardial injury after both surgery and exacerbation of COPD. In stroke patients, a study found a higher mortality in patients that experienced hypoxemia, but after adjusting for National Institute of Health Stroke Scale and age, this association was not significant. In the study, hypoxemia was found at all stages during admission. Using continuous monitoring for 48 hours a study found that hypoxemia was common and prolonged in patients recovering from noncardiac surgery. Furthermore, this study showed that 90% of hypoxemic episodes SpO2 < 90% for at least one hour went undetected by standard spot checks, which were typically conducted at intervals of 4-6 hours.
Trauma patients can also be characterized as high-risk patients due to a high mortality. The incidence of prehospital hypoxemia in traumatic brain injury patients has been studied, a study found a prevalence of 37.9%,11 and another study discovered that prehospital hypoxemia was associated with higher mortality. Evidence about the incidence of hypoxemia in trauma patients after admission to a hospital is not well established. There is reason to suspect that trauma patients can experience episodes of hypoxemia after admission and that the incidence of hypoxemia may differ between day and night as shown in several other patient populations. Potential incidences of severe hypoxemia, from patients being admitted to a trauma centre to subsequent care in a ward, should be avoided, since severe hypoxemia is associated with harmful effects. Hypoxemia can be detected and potentially corrected with more advanced measuring equipment. It is relevant to conduct a study with the purpose of determining the occurrence and distribution over the first 24 hours after hospital admission of hypoxemia by continuous SpO2 monitoring in trauma patients, since this could potentially have important clinical implications and be useful in improving patient outcomes.
This study is a single centre study of trauma patients at Rigshospitalet, Denmark. Rigshospitalet holds the only major trauma centre in the eastern part of Denmark, and every year around 1000 trauma patients are treated here. Patients are admitted from the Capital Region of Denmark with around 1.9 million inhabitants and the Region of Zealand with around 850.000 inhabitants.
All patients with trauma team activation in the trauma bay at Rigshospitalet, including both direct transport and secondary transfers, will be screened for potential inclusion in the study.
The trauma bay at Rigshospitalet will be equipped with the oximetry equipment, and measurement can be started as early as possible. At the trauma bay, a doctor will conduct the screening and inclusion of patients to the study at arrival. After study inclusion, monitoring equipment will be attached by a nurse in the trauma bay. Subsequently a member of the study investigator group will obtain consent.
Continuous pulse oximetry will be used to measure SpO2. SpO2, heart rate, pulse amplitude and alarm status will be measured every second during a 24-hour period on all study participants.
The Nellcor™ Portable SpO2 Patient Monitoring System, PM10N (Medtronic, 15 Hampshire Street, Mansfield, MA 02048, USA) is used as monitoring device. The Covidien Nellcor FLEXMAX or a similar probe will be placed on the patients' index finger, alternatively another finger or toe.
Data collection will continue for up to 24 hours. If there is an untimely removal of the probe, the device will switch of, and data collection will stop at this point, unless the device is turned on again. After 24 hours of measurement, an investigator will collect the device and transfer the data by USB cable to a computer for secure storage and further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with trauma team activation in the trauma bay at Rigshospitalet, including both direct transport and secondary transfers, will be screened for potential inclusion in the study. Patients will be included if they comply with the above eligibility criteria
Key inclusion criteria (4 listed)
- Patients aged ≥18 years
- Blunt or penetrating mechanism of trauma
- Trauma team activation
- Admission to a ward/ICU from trauma centre
Key exclusion criteria (4 listed)
- Patients with a suspicion of carbon monoxide intoxication
- No applicable finger or toe for sensor attachment
- Trauma team activation was cancelled
- No available pulse oximeter at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse oximeterNo real intervention, but all study participants will have an additional pulse oximeter attached, to measure oxygen saturation. | Other | – |
Primary outcome
Occurrence of Hypoxemia
Time frame: 24 hours
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.
3 secondary outcomes
Location of Hypoxemia (Specific Departments)
Time frame: 24 hours
Prolonged Hypoxemic Episodes
Time frame: 24 hours
Cumulated Time of Hypoxemia
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33539662Zulazmi NA, Arulsamy A, Ali I, Zainal Abidin SA, Othman I, Shaikh MF. The utilization of small non-mammals in traumatic brain injury research: A systematic review. CNS Neurosci Ther. 2021 Apr;27(4):381-402. doi: 10.1111/cns.13590. Epub 2021 Feb 4.
- Background: PubMed 23609291ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.
- Background: PubMed 30855920Rhodes CE, Denault D, Varacallo MA. Physiology, Oxygen Transport. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK538336/
- Background: PubMed 26709054Lopez-Barneo J, Ortega-Saenz P, Gonzalez-Rodriguez P, Fernandez-Aguera MC, Macias D, Pardal R, Gao L. Oxygen-sensing by arterial chemoreceptors: Mechanisms and medical translation. Mol Aspects Med. 2016 Feb-Mar;47-48:90-108. doi: 10.1016/j.mam.2015.12.002. Epub 2015 Dec 18.
- Background: PubMed 34924022Singer M, Young PJ, Laffey JG, Asfar P, Taccone FS, Skrifvars MB, Meyhoff CS, Radermacher P. Dangers of hyperoxia. Crit Care. 2021 Dec 19;25(1):440. doi: 10.1186/s13054-021-03815-y.
- Background: PubMed 29982208Eskesen TG, Baekgaard JS, Steinmetz J, Rasmussen LS. Initial use of supplementary oxygen for trauma patients: a systematic review. BMJ Open. 2018 Jul 6;8(7):e020880. doi: 10.1136/bmjopen-2017-020880.
- Background: PubMed 35247272Loft FC, Rasmussen SM, Elvekjaer M, Haahr-Raunkjaer C, Sorensen HBD, Aasvang EK, Meyhoff CS; WARD-Project Group. Continuously monitored vital signs for detection of myocardial injury in high-risk patients - An observational study. Acta Anaesthesiol Scand. 2022 Jul;66(6):674-683. doi: 10.1111/aas.14056. Epub 2022 Mar 14.
- Background: PubMed 16388191Rowat AM, Dennis MS, Wardlaw JM. Hypoxaemia in acute stroke is frequent and worsens outcome. Cerebrovasc Dis. 2006;21(3):166-72. doi: 10.1159/000090528. Epub 2005 Dec 23.
- Background: PubMed 26287299Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
- Background: PubMed 18323023Murdock D. Trauma: when there's no time to count. AORN J. 2008 Feb;87(2):322-8. doi: 10.1016/j.aorn.2007.07.008.
- Background: PubMed 25214252Stassen W, Welzel T. The prevalence of hypotension and hypoxaemia in blunt traumatic brain injury in the prehospital setting of Johannesburg, South Africa: A retrospective chart review. S Afr Med J. 2014 May 12;104(6):424-7. doi: 10.7196/samj.7494.
- Background: PubMed 17099519Chi JH, Knudson MM, Vassar MJ, McCarthy MC, Shapiro MB, Mallet S, Holcroft JJ, Moncrief H, Noble J, Wisner D, Kaups KL, Bennick LD, Manley GT. Prehospital hypoxia affects outcome in patients with traumatic brain injury: a prospective multicenter study. J Trauma. 2006 Nov;61(5):1134-41. doi: 10.1097/01.ta.0000196644.64653.d8.
- Data from TraumacentreLink provided by the sponsor.
- Link on statisticsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Steinmetz, MD,professor principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Trauma Injury, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Hypoxemia (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256692, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.