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出境医 / 临床实验 / Brain Oxygenation During Prehospital Anesthesia (BOPRA-P)

Brain Oxygenation During Prehospital Anesthesia (BOPRA-P)

Study Description
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.

Condition or disease Intervention/treatment
Critical Illness Device: Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 30, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Disturbance-free time of the total monitoring time [ Time Frame: Prehospital phase ]
    Proportion of time with readable monitor signal of the total time monitor connected to the patient

  2. Cerebral desaturation events [ Time Frame: During prehospital phase after induction of anesthesia ]
    Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes


Secondary Outcome Measures :
  1. On-scene time [ Time Frame: Prehospital phase ]
    Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation

  2. Qualitative feedback from HEMS crews [ Time Frame: Prehospital phase ]
    Comments on the usability of the study device

  3. Survival [ Time Frame: 30 days, 12 months ]
    Data from population registry center

  4. Neurologic disability [ Time Frame: 30 days, 12 months ]
    3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse

  5. Health related quality of life [ Time Frame: 12 months ]
    total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life)


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 14, 2019
Last Update Posted Date February 16, 2021
Actual Study Start Date May 20, 2019
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2019)
  • Disturbance-free time of the total monitoring time [ Time Frame: Prehospital phase ]
    Proportion of time with readable monitor signal of the total time monitor connected to the patient
  • Cerebral desaturation events [ Time Frame: During prehospital phase after induction of anesthesia ]
    Number of patients with forehead regional oxygen saturation ≤50% for ≥5 minutes
Original Primary Outcome Measures
 (submitted: May 10, 2019)
  • Disturbance-free time of the total monitoring time [ Time Frame: Prehospital phase ]
    Proportion of time with readable monitor signal of the total time monitor connected to the patient
  • Cerebral desaturation events [ Time Frame: During prehospital phase after induction of anesthesia ]
    Forehead regional oxygen saturation ≤50% for ≥5 minutes
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2019)
  • On-scene time [ Time Frame: Prehospital phase ]
    Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation
  • Qualitative feedback from HEMS crews [ Time Frame: Prehospital phase ]
    Comments on the usability of the study device
  • Survival [ Time Frame: 30 days, 12 months ]
    Data from population registry center
  • Neurologic disability [ Time Frame: 30 days, 12 months ]
    3-6 on modified Rankin scale (range from 0 [no symptoms at all] to 6 [dead], evaluated by trained research nurse
  • Health related quality of life [ Time Frame: 12 months ]
    total score of 15-D questionnaire including 15 dimensions each ranked from 1 (good quality of life) to 5 (poor quality of life)
Original Secondary Outcome Measures
 (submitted: May 10, 2019)
  • On-scene time [ Time Frame: Prehospital phase ]
    Time from arrival of helicopter emergency medical services unit on the patient to beginning of transportation
  • Qualitative feedback from HEMS crews [ Time Frame: Prehospital phase ]
    Comments on the usability of the study device
  • Survival [ Time Frame: 30 days, 12 months ]
    Data from population registry center
  • Neurologic disability (mRS) [ Time Frame: 30 days, 12 months ]
    modified Rankin scale, evaluated by trained research nurse
  • Quality of life (15D) [ Time Frame: 12 months ]
    15-D instrument
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Oxygenation During Prehospital Anesthesia
Official Title Brain Oxygenation During Prehospital Anesthesia: an Observational Pilot Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 10, 2019) 		100
Original Estimated Enrollment Same as current
Actual Study Completion Date September 30, 2020
Actual Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948711
Other Study ID Numbers BOPRA-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jouni Nurmi, MD, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
Collaborators
  • Oulu University Hospital
  • FinnHEMS
Investigators Not Provided
PRS Account Helsinki University Central Hospital
Verification Date February 2021

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