The main aim is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours after trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and ARDS) within 30 days (combined…
ID
Source
Brief title
Condition
- Other condition
- Injuries NEC
Synonym
Health condition
lichamelijk trauma na ongeval
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be a combined endpoint of 30-day mortality
and/or major respiratory complications (pneumonia and ARDS) within 30 days.
Secondary outcome
The secondary outcome measures will be mortality at 30 days and 12 months after
trauma, major respiratory complications (pneumonia and ARDS) within 30 days,
hospital length of stay (HLOS), Intensive Care Unit length of stay (ICU LOS)
and days alive outside the ICU, time on mechanical ventilation (until 30 days),
days alive without mechanical ventilation and number of re-intubations within
30 days, pneumonia post-discharge within 30 days, episodes of hypoxaemia during
intervention (saturation <90%), surgical site infections within 30 days,
EQ-5D-5L score at 6 months and 12 months post-trauma, and GOSE score at 6
months and 12 months post-trauma.
Background summary
In the trauma population, oxygen administration is often standard of care.
However, the evidence supporting oxygen administration in this population is
extremely limited. In a recent pilot study (TRAUMOX1), we found evidence that
maintenance of normoxaemia following trauma is feasible. Furthermore, we found
that the incidence of mortality and lung complications tended to be higher
amongst hyperoxemic patients.
In TRAUMOX2, we hypothesize that a restrictive compared to a liberal oxygen
strategy for the initial eight hours after trauma will result in a lower rate
of 30-day mortality and/or major respiratory complications (pneumonia and ARDS)
within 30 days (combined endpoint).
Study objective
The main aim is to compare the effect of a restrictive versus liberal oxygen
strategy the first eight hours after trauma on the incidence of 30-day
mortality and/or major respiratory complications (pneumonia and ARDS) within 30
days (combined endpoint).
Study design
An international, multicentre, parallel-grouped, superiority, outcome assessor-
and analyst-blinded, randomised, controlled, clinical trial with regards to
treatment: treating staff will be aware of the randomisation group.
Intervention
Restrictive (intervention) versus liberal (control) oxygen treatment.
Study burden and risks
In the restrictive oxygen group, the risk of hypoxia is avoided as all trial
participants are monitored closely during the eight hours intervention with
continuous pulse-oximetry and arterial blood gases to avoid desaturations.
Liberal oxygen treatment is similar to the current guidelines, and thus there
will be no additional risk compared to trial participants not enrolled in the
study.
Inge Lehmanns Vej 6, opgang 6, 1. sal
København 2100
DK
Inge Lehmanns Vej 6, opgang 6, 1. sal
København 2100
DK
Listed location countries
Age
Inclusion criteria
1) Patients aged >=18 years, including fertile women*
2) Blunt or penetrating trauma mechanism
3) Direct transfer from the scene of accident to one of the participating
trauma centres
4) Trauma team activation (basic or extended trauma team)
5) The enrolling physician must initially expect a hospital length of stay for
24 hours or longer
6) Deferred consent by patient or proxy
Exclusion criteria
1) Patients in cardiac arrest before or on admission
2) Patients with a suspicion of carbon monoxide intoxication
3) Patients with no/minor injuries after secondary survey will be excluded if
they are expected to be discharged <24 hours
4) Insufficient comprehension of Dutch language (also applies to person
providing proxy consent)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinicaltrials.gov Registration number: NCT03491644 |
| EudraCT | EUCTR2021-000556-19-NL |
| CCMO | NL79921.078.21 |