Brain Oxygenation During Prehospital Anesthesia (BOPRA-P)

Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study

The study will evaluate the feasibility of Nonin SenSmart H500 device to measuring brain oxygenation during prehospital anesthesia of adult patient. The study also estimates the incidence of cerebral hypoxic events of anesthetized patients during prehospital care. The study does not affect the treatment of the patient. The study is pilot study and will be followed with a main study to assess the association between cerebral oxygenation during prehospital care and outcome of the patient.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029
    • FinnHEMS 50 / Oulu University Hospital
  • Vantaa, Finland, 01530
    • FinnHEMS 10 / Helsinki Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill or trauma patients undergoing prehospital anesthesia and endotracheal intubation for any reason by helicopter emergency medical team providing critical care.

Description

Inclusion Criteria:

• sedation or anesthesia provided to facilitate endotracheal intubation, performed by HEMS team regardless of the reason

Exclusion Criteria:

• Cardiac arrest at the time of intubation
• Physical barrier for NIRS measuring (e.g. forehead laceration)
• HEMS physician does not escort patient to the hospital (and patient is not dead on the scene after inclusion)
• Workload too high to ensure standard level of clinical care during the study
• Known special vulnerability including known mental disability (permanent, not related to acute condition), patients in nursing homes, prisoners and forensic psychiatric patients.
• Known or evident pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disturbance-free time of the total monitoring time	Proportion of time with readable monitor signal of the total time monitor connected to the patient	Prehospital phase
Cerebral desaturation events	Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes	During prehospital phase after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
On-scene time	Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation	Prehospital phase
Qualitative feedback from HEMS crews	Comments on the usability of the study device	Prehospital phase
Survival	Data from population registry center	30 days, 12 months
Neurologic disability	3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse	30 days, 12 months
Health related quality of life	total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life)	12 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Oulu University Hospital; FinnHEMS

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): September 2, 2019
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: BOPRA-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No