Restrictive Vs. Liberal Oxygen in Trauma

Summary

Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications and diminished quality of life after trauma. According to Advanced Trauma Life Support guidelines, all severely injured trauma patients should receive supplemental oxygen. The objective of TRAUMOX2 is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours following trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint).

Timeline

Start

2021-12-10

Primary completion

2023-10-12

Completion

2024-10-12

Publications

• Arleth T, Baekgaard J, Siersma V, Creutzburg A, Dinesen F, Rosenkrantz O, Heiberg J, Isbye D, Mikkelsen S, Hansen PM, Zwisler ST, Darling S, Petersen LB, Morkeberg MCR, Andersen M, Fenger-Eriksen C, Bach PT, Van Vledder MG, Van Lieshout EMM, Ottenhof NA, Maissan IM, Den Hartog D, Hautz WE, Jakob DA, Iten M, Haenggi M, Albrecht R, Hinkelbein J, Klimek M, Rasmussen LS, Steinmetz J; TRAUMOX2 Trial Group. Early Restrictive vs Liberal Oxygen for Trauma Patients: The TRAUMOX2 Randomized Clinical Trial. JAMA. 2025 Feb 11;333(6):479-489. doi: 10.1001/jama.2024.25786.
• Arleth T, Baekgaard J, Siersma V, Klimek M, Hinkelbein J, Rasmussen LS, Steinmetz J; TRAUMOX2 Study Group. Comparing restrictive versus liberal oxygen strategies for trauma patients: The TRAUMOX2 trial-Statistical analysis plan. Acta Anaesthesiol Scand. 2023 Jul;67(6):829-838. doi: 10.1111/aas.14230. Epub 2023 Mar 28.
• Baekgaard J, Arleth T, Siersma V, Hinkelbein J, Yucetepe S, Klimek M, van Vledder MG, Van Lieshout EMM, Mikkelsen S, Zwisler ST, Andersen M, Fenger-Eriksen C, Isbye DL, Rasmussen LS, Steinmetz J. Comparing restrictive versus liberal oxygen strategies for trauma patients - the TRAUMOX2 trial: protocol for a randomised clinical trial. BMJ Open. 2022 Nov 7;12(11):e064047. doi: 10.1136/bmjopen-2022-064047.

Drugs

Indications

No indication recorded.