Brain Oxygenation During Prehospital Anesthesia: an Observational Study

Active, not recruiting

• Conditions: Anesthesia; Major Trauma; Emergencies; Critically Ill
• Interventions: Diagnostic Test: Cerebral near-infrared spectroscopy

• Registration Number: NCT04144803
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Study Start: 2019-11-18
• Primary Completion: 2022-09-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

• sedation or anesthesia provided to facilitate endotracheal intubation, performed by Helicopter Emergency Medical Services (HEMS) team regardless of the reason

Exclusion Criteria

• Ongoing cardiopulmonary resuscitation at the time of intubation
• Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)
• HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included)
• Workload too high to ensure standard level of clinical care during the study
• For interviews: no competence in Finnish, Swedish or English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerebral desaturation group	Cerebral near-infrared spectroscopy	absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia
Control group	Cerebral near-infrared spectroscopy	no absolute drop of forehead cerebral oxygen saturation ≥ 10% from baseline for ≥ 5 minutes during prehospital anesthesia

Primary Outcome Measures

Name	Time	Method
Favorable neurological outcome	30 days	modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)
Cerebral desaturation event	through prehospital care, approximately 60 minutes	an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes

Secondary Outcome Measures

Name	Time	Method
15D score	1 year	Heal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL)
Survival	365 days	Survival
Favorable neurological outcome	1 year	modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)

Trial Locations

Locations (6)

FinnHEMS 51 / Lapland hospital district; 🇫🇮 Rovaniemi, Finland

FinnHEMS 10 / Helsinki University Hospital; 🇫🇮 Vantaa, Finland

FinnHEMS 60 / Kuopio University Hospital; 🇫🇮 Kuopio, Finland

FinnHEMS 50 / Oulu University Hospital; 🇫🇮 Oulu, Finland

FinnHEMS 20 / Turku University Hospital; 🇫🇮 Turku, Finland

FinnHEMS 30 / Tampere University Hospital; 🇫🇮 Tampere, Finland