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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03948711
Other study ID # BOPRA-P
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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