Brain Oxygenation During Prehospital Anesthesia

NCT03948711 | Completed

• 1 other identifier: BOPRA-P
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• On-scene time

  Prehospital phase

• Qualitative feedback from HEMS crews

  Prehospital phase

• Survival

  30 days, 12 months

• Neurologic disability

  30 days, 12 months

• Health related quality of life

  12 months

Interventions

Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation DEVICE

Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Cardiac arrest at the time of intubation
• Physical barrier for NIRS measuring (e.g. forehead laceration)
• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Oulu University Hospital: collaborator
• FinnHEMS: collaborator

Study Sites (2)

FinnHEMS 50 / Oulu University Hospital

Oulu, 90029, Finland

Location

FinnHEMS 10 / Helsinki Univeristy Hospital

Vantaa, 01530, Finland

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior HEMS physician, associate professor

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: May 20, 2019
• Primary Completion: September 2, 2019
• Study Completion: September 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)