Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial

Josefine Baekgaard; Tobias Arleth; Volkert Siersma; Jochen Hinkelbein; Sirin Yücetepe; Markus Klimek; Mark G. Van Vledder; Esther M.M. Van Lieshout; Søren Mikkelsen; Stine Thorhauge Zwisler; Mikkel Andersen; Christian Fenger-Eriksen; Dan L. Isbye; Lars S. Rasmussen; Jacob Steinmetz

doi:10.1136/bmjopen-2022-064047

Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial

Josefine Baekgaard^*, Tobias Arleth, Volkert Siersma, Jochen Hinkelbein, Sirin Yücetepe, Markus Klimek, Mark G. Van Vledder, Esther M.M. Van Lieshout, Søren Mikkelsen, Stine Thorhauge Zwisler, Mikkel Andersen, Christian Fenger-Eriksen, Dan L. Isbye, Lars S. Rasmussen, Jacob Steinmetz

^*Corresponding author for this work

Department of Clinical Medicine - Anaesthesiology and Operation, Intensive care

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

Abstract

Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial. Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO 2 of 94%. The liberal group receives 12-15 L O 2 /min or FiO 2 =0.6-1.0. The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal. Trial registration numbers EudraCT 2021-000556-19; NCT05146700.

Original language	English
Article number	e064047
Journal	BMJ Open
Volume	12
Issue	11
Number of pages	9
ISSN	2044-6055
DOIs	https://doi.org/10.1136/bmjopen-2022-064047
Publication status	Published - Nov 2022

Keywords

Adult anaesthesia
Adult intensive & critical care
Respiratory physiology
TRAUMA MANAGEMENT

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10.1136/bmjopen-2022-064047Licence: CC BY-NC

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Baekgaard, J., Arleth, T., Siersma, V., Hinkelbein, J., Yücetepe, S., Klimek, M., Van Vledder, M. G., Van Lieshout, E. M. M., Mikkelsen, S., Zwisler, S. T., Andersen, M., Fenger-Eriksen, C., Isbye, D. L., Rasmussen, L. S., & Steinmetz, J. (2022). Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial. BMJ Open, 12(11), Article e064047. https://doi.org/10.1136/bmjopen-2022-064047

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title = "Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial",

abstract = "Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial. Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO 2 of 94%. The liberal group receives 12-15 L O 2 /min or FiO 2 =0.6-1.0. The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal. Trial registration numbers EudraCT 2021-000556-19; NCT05146700.",

keywords = "Adult anaesthesia, Adult intensive & critical care, Respiratory physiology, TRAUMA MANAGEMENT",

author = "Josefine Baekgaard and Tobias Arleth and Volkert Siersma and Jochen Hinkelbein and Sirin Y{\"u}cetepe and Markus Klimek and {Van Vledder}, {Mark G.} and {Van Lieshout}, {Esther M.M.} and S{\o}ren Mikkelsen and Zwisler, {Stine Thorhauge} and Mikkel Andersen and Christian Fenger-Eriksen and Isbye, {Dan L.} and Rasmussen, {Lars S.} and Jacob Steinmetz",

note = "Publisher Copyright: {\textcopyright} ",

year = "2022",

month = nov,

doi = "10.1136/bmjopen-2022-064047",

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Baekgaard, J, Arleth, T, Siersma, V, Hinkelbein, J, Yücetepe, S, Klimek, M, Van Vledder, MG, Van Lieshout, EMM, Mikkelsen, S, Zwisler, ST, Andersen, M, Fenger-Eriksen, C, Isbye, DL, Rasmussen, LS & Steinmetz, J 2022, 'Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial', BMJ Open, vol. 12, no. 11, e064047. https://doi.org/10.1136/bmjopen-2022-064047

Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial. / Baekgaard, Josefine; Arleth, Tobias; Siersma, Volkert et al.
In: BMJ Open, Vol. 12, No. 11, e064047, 11.2022.

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaper › Journal article › Research › peer-review

TY - JOUR

T1 - Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial

T2 - protocol for a randomised clinical trial

AU - Baekgaard, Josefine

AU - Arleth, Tobias

AU - Siersma, Volkert

AU - Hinkelbein, Jochen

AU - Yücetepe, Sirin

AU - Klimek, Markus

AU - Van Vledder, Mark G.

AU - Van Lieshout, Esther M.M.

AU - Mikkelsen, Søren

AU - Zwisler, Stine Thorhauge

AU - Andersen, Mikkel

AU - Fenger-Eriksen, Christian

AU - Isbye, Dan L.

AU - Rasmussen, Lars S.

AU - Steinmetz, Jacob

PY - 2022/11

Y1 - 2022/11

N2 - Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial. Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO 2 of 94%. The liberal group receives 12-15 L O 2 /min or FiO 2 =0.6-1.0. The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal. Trial registration numbers EudraCT 2021-000556-19; NCT05146700.

AB - Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial. Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>21%) that ensures an SpO 2 of 94%. The liberal group receives 12-15 L O 2 /min or FiO 2 =0.6-1.0. The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website (www.traumox2.org) is available for updates and study results will be published in an international peer-reviewed scientific journal. Trial registration numbers EudraCT 2021-000556-19; NCT05146700.

KW - Adult anaesthesia

KW - Adult intensive & critical care

KW - Respiratory physiology

KW - TRAUMA MANAGEMENT

UR - http://www.scopus.com/inward/record.url?scp=85141894352&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2022-064047

DO - 10.1136/bmjopen-2022-064047

M3 - Journal article

C2 - 36344005

AN - SCOPUS:85141894352

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 11

M1 - e064047

ER -

Comparing restrictive versus liberal oxygen strategies for trauma patients-the TRAUMOX2 trial: protocol for a randomised clinical trial

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Keywords

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