Brain Oxygenation During Prehospital Anesthesia

Critical Illness Clinical Trial

— BOPRA-P  

Official title:

Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948711
• Other study ID #: BOPRA-P
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation
Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.

Locations

Country	Name	City	State
Finland	FinnHEMS 50 / Oulu University Hospital	Oulu
Finland	FinnHEMS 10 / Helsinki Univeristy Hospital	Vantaa

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	FinnHEMS, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cerebral desaturation events	Number of patients with forehead regional oxygen saturation =50% for =5 minutes	During prehospital phase after induction of anesthesia
Secondary	On-scene time	Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation	Prehospital phase
Secondary	Qualitative feedback from HEMS crews	Comments on the usability of the study device	Prehospital phase
Secondary	Survival	Data from population registry center	30 days, 12 months
Secondary	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
Secondary	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