Comparing restrictive versus liberal oxygen strategies for trauma patients: The TRAUMOX2 trial—Statistical analysis plan
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Comparing restrictive versus liberal oxygen strategies for trauma patients : The TRAUMOX2 trial—Statistical analysis plan. / Arleth, Tobias; Baekgaard, Josefine; Siersma, Volkert; Klimek, Markus; Hinkelbein, Jochen; Rasmussen, Lars Simon; Steinmetz, Jacob; for The TRAUMOX2 Study Group.
I: Acta Anaesthesiologica Scandinavica, Bind 67, Nr. 6, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Comparing restrictive versus liberal oxygen strategies for trauma patients
T2 - The TRAUMOX2 trial—Statistical analysis plan
AU - Arleth, Tobias
AU - Baekgaard, Josefine
AU - Siersma, Volkert
AU - Klimek, Markus
AU - Hinkelbein, Jochen
AU - Rasmussen, Lars Simon
AU - Steinmetz, Jacob
AU - for The TRAUMOX2 Study Group
N1 - Publisher Copyright: © 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
PY - 2023
Y1 - 2023
N2 - Background: The international advanced trauma life support guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for 8 h. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). This manuscript presents the statistical analysis plan for TRAUMOX2. Methods: Patients are randomised 1:1 in variable block sizes of four, six and eight, stratified by including centre (pre-hospital base or trauma centre) and tracheal intubation at inclusion. The trial will include 1420 patients to be able to detect a 33% relative risk reduction with the restrictive oxygen strategy of the composite primary outcome with 80% power at the 5% significance level. We will conduct modified intention-to-treat analyses on all randomised patients and per-protocol analyses for the primary composite outcome and key secondary outcomes. The primary composite outcome and two key secondary outcomes will be compared between the two allocated groups using logistic regression reported as odds ratios with 95% confidence intervals adjusted for the stratification variables as in the primary analysis. A p-value below 5% will be considered statistically significant. A Data Monitoring and Safety Committee has been established to conduct interim analyses after inclusion of 25% and 50% of the patients. Conclusion: This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients. Trial Registration: EudraCT number: 2021–000556-19; ClinicalTrials.gov identifier: NCT05146700 (date of registration: 7 December 2021).
AB - Background: The international advanced trauma life support guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for 8 h. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). This manuscript presents the statistical analysis plan for TRAUMOX2. Methods: Patients are randomised 1:1 in variable block sizes of four, six and eight, stratified by including centre (pre-hospital base or trauma centre) and tracheal intubation at inclusion. The trial will include 1420 patients to be able to detect a 33% relative risk reduction with the restrictive oxygen strategy of the composite primary outcome with 80% power at the 5% significance level. We will conduct modified intention-to-treat analyses on all randomised patients and per-protocol analyses for the primary composite outcome and key secondary outcomes. The primary composite outcome and two key secondary outcomes will be compared between the two allocated groups using logistic regression reported as odds ratios with 95% confidence intervals adjusted for the stratification variables as in the primary analysis. A p-value below 5% will be considered statistically significant. A Data Monitoring and Safety Committee has been established to conduct interim analyses after inclusion of 25% and 50% of the patients. Conclusion: This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients. Trial Registration: EudraCT number: 2021–000556-19; ClinicalTrials.gov identifier: NCT05146700 (date of registration: 7 December 2021).
KW - injury
KW - oxygen
KW - statistics
KW - trauma
KW - TRAUMOX2
U2 - 10.1111/aas.14230
DO - 10.1111/aas.14230
M3 - Journal article
C2 - 36906804
AN - SCOPUS:85151680437
VL - 67
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 6
ER -
ID: 342826231