Intermediate Normal Versus High Normal Oxygen Levels in the Emergency Department for Severe Traumatic Brain Injury

NCT05464277 | Terminated

• 1 other identifier: 286/18-6-2020
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

Despite almost universal usage of supplemental oxygen therapy in patients presenting in the emergency department with traumatic brain injury (TBI), optimal oxygen levels are unclear. The investigators propose a pilot multi-center randomized controlled trial to test the hypothesis that maintaining intermediate normal as opposed to high normal oxygen levels in patients presenting in the emergency department with TBI is feasible, and to obtain preliminary data on the efficacy of the two approaches to oxygen therapy. The aim is that the investigators produce pilot data, which could inform the design of potential subsequent larger clinical trials.

Conditions

Traumatic Brain Injury; Acute Respiratory Failure; Acute Respiratory Distress Syndrome; Acute Brain Injury

Keywords

emergency care; acute respiratory failure; trauma; oxygen; disability; acute care; critical care; mortality; brain injury; mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• Mean area-under-curve (AUC) for SpO2

  SpO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study.

  Measurements will be obtained each hour for a total duration of 6 hours from intubation.

• Mean area-under-curve (AUC) for FiO2

  FiO2 will be recorded each hour for a total duration of 6 hours from intubation. Subsequently, mean area-under-curve (AUC) will be calculated for each group. This will demonstrate the feasibility of the study.

  Measurements will be obtained each hour for a total duration of 6 hours from intubation.

• PaO2

  PaO2 will be recorded at least once during 6 hours from intubation. Subsequently, PaO2 values (mmHg) will be calculated for each group. This will demonstrate the feasibility of the study.

  Measurements will be obtained at least once during 6 hours from intubation.

Secondary Outcomes (4)

• Nosocomial pneumonia

  Within 7 days of subject enrollment

• Acute Respiratory Distress Syndrome (ARDS)

  Within 7 days of subject enrollment

• All-cause mortality

  Within 28 days of subject enrollment

• Extended Glasgow Outcome Score (GOS-E)

  At 6 months following subject enrollment

Study Arms (2)

Intermediate normal oxygen

ACTIVE COMPARATOR

For the "intermediate normal oxygen" group, an oxygen saturation by pulse oximetry (SpO2) of 95-97% will be recommended in the light of the Improving Oxygen Therapy in Acute-illness (IOTA) meta-analysis. The acceptable lower limit of PaO2 will be set to 80 mmHg according to a recent consensus of experts endorsed by the European Society of Intensive Care Medicine. The lower-limit and higher-limit monitor alarm for SpO2 will be set at 94% and 98%, respectively. In case that the emergency department of a study site uses ventilators, which allow for only two options of FiO2 titration (namely, "air mix" and "FiO2 of 1.0"), then the "intermediate normal oxygen" group should receive "air mix".

Other: Oxygen

High normal oxygen

ACTIVE COMPARATOR

For the "high normal oxygen" group, an oxygen saturation by pulse oximetry (SpO2) of 99-100% will be recommended. The lower-limit monitor alarm for SpO2 will be set at 98%. No upper alarm limit for SpO2 will be set. In case that the emergency department of a study site uses ventilators, which allow for only two options of FiO2 titration (namely, "air mix" and "FiO2 of 1.0"), then the "high normal oxygen" group should receive "FiO2 of 1.0".

Other: Oxygen

Interventions

Oxygen OTHER

Oxygen to achieve assigned SpO2 (or FiO2) targets will be administered to study subjects. The treating clinician can alter oxygenation targets at any time if deemed necessary. The oxygenation goal will be based on SpO2 rather than arterial oxygen saturation (SaO2) or arterial pressure oxygen (PaO2) from arterial blood gases. However, PaO2 can be used instead in situations where the treating clinician considers that peripheral perfusion is poor or SpO2 readings are unreliable. Assigned SpO2 targets will apply to the study subjects for a total duration of 6 hours from intubation or until death or until transfer to the operating theater (whatever comes first).

High normal oxygen; Intermediate normal oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient ≥18 years
• Glasgow Coma Scale ≤ 8
• Non-penetrating traumatic brain injury
• Intubated patient

You may not qualify if:

• Age \<18 years
• Lack of intention to admit to the intensive care unit
• Moribund patient expected to die within 24 hours
• Expected need for mechanical ventilation \< 24 hours
• Time interval from intubation to group allocation more than 60 minutes
• Penetrating traumatic brain injury
• Pregnancy
• Lack of equipoise of the treating clinician
• Lack of informed consent

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (2)

Evangelismos Hospital

Athens, 10676, Greece

Location

KAT General Hospital

Athens, 14561, Greece

Location

Related Publications (19)

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MeSH Terms

Conditions

Brain Injuries, Traumatic; Respiratory Distress Syndrome; Brain Injuries; Wounds and Injuries

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Ilias I Siempos, MD, DSc

  Evangelismos Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To avoid selection bias, the allocation sequence will be blinded from researchers involved in patient enrolment. Although study subjects will be unaware of the assigned group, blinding of treating clinicians is not considered feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Scholar

Model Details: Enrolled patients will be randomly allocated using opaque sealed envelopes to either "intermediate normal oxygen" or "high normal oxygen" group. The asymptomatic maximal procedure, with an allocation ratio of 1:1 and a maximum tolerated imbalance of 2 will be used to randomize subjects.

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 19, 2022
• Study Start: December 2, 2022
• Primary Completion: July 14, 2024
• Study Completion: July 14, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)