NCT06256692

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 5, 2024

Results QC Date

March 26, 2026

Last Update Submit

April 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (3)

  • Location of Hypoxemia (Specific Departments)

    24 hours

  • Prolonged Hypoxemic Episodes

    24 hours

  • Cumulated Time of Hypoxemia

    24 hours

Interventions

No real intervention, but all study participants will have an additional pulse oximeter attached, to measure oxygen saturation.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Patients aged ≥18 years
  • Blunt or penetrating mechanism of trauma
  • Trauma team activation
  • Admission to a ward/ICU from trauma centre

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Region H, 2100, Denmark

Location

Related Publications (16)

  • 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.

    PMID: 33539662BACKGROUND
  • ATLS 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.

    PMID: 23609291BACKGROUND
  • Rhodes 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/

    PMID: 30855920BACKGROUND
  • Lopez-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.

    PMID: 26709054BACKGROUND
  • Singer 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.

    PMID: 34924022BACKGROUND
  • Eskesen 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.

    PMID: 29982208BACKGROUND
  • Loft 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.

    PMID: 35247272BACKGROUND
  • Rowat 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.

    PMID: 16388191BACKGROUND
  • Sun 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.

    PMID: 26287299BACKGROUND
  • Murdock 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.

    PMID: 18323023BACKGROUND
  • Stassen 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.

    PMID: 25214252BACKGROUND
  • Chi 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.

    PMID: 17099519BACKGROUND
  • Ali 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.

    PMID: 18035240BACKGROUND
  • Fanfulla 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.

    PMID: 18274273BACKGROUND
  • Galatius-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.

    PMID: 8068464BACKGROUND
  • Jensen-Abbew J, Tsuchiya EA, Arleth T, Dinesen F, Queitsch CJ, Von Magius M, Christensen MI, Madsen KPD, Rosenkrantz O, Steinmetz J. Occurrence of Hypoxemia the First Day After Trauma Assessed by Continuous Pulse Oximetry. Acta Anaesthesiol Scand. 2026 Apr;70(4):e70220. doi: 10.1111/aas.70220.

Related Links

MeSH Terms

Conditions

Wounds and InjuriesAccidental InjuriesHypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jacob Jensen-Abbew
Organization
Department of Anaesthesiology, Centre of Head and Orthopaedics, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark

Study Officials

  • Jacob Steinmetz, MD,professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

February 20, 2024

Primary Completion

August 24, 2024

Study Completion

September 5, 2024

Last Updated

April 21, 2026

Results First Posted

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations