Anesthesia Clinical Trial
— BOPRAOfficial title:
Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)
Verified date | October 2022 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.
Status | Active, not recruiting |
Enrollment | 1300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | September 25, 2022 |
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 Helicopter Emergency Medical Services (HEMS) team regardless of the reason Exclusion Criteria: - Ongoing cardiopulmonary resuscitation at the time of intubation - Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration) - HEMS unit does not escort patient to the hospital (exception: in case of death on scene after inclusion, patient is included) - Workload too high to ensure standard level of clinical care during the study - For interviews: no competence in Finnish, Swedish or English |
Country | Name | City | State |
---|---|---|---|
Finland | FinnHEMS 60 / Kuopio University Hospital | Kuopio | |
Finland | FinnHEMS 50 / Oulu University Hospital | Oulu | |
Finland | FinnHEMS 51 / Lapland hospital district | Rovaniemi | |
Finland | FinnHEMS 30 / Tampere University Hospital | Tampere | |
Finland | FinnHEMS 20 / Turku University Hospital | Turku | |
Finland | FinnHEMS 10 / Helsinki University Hospital | Vantaa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | FinnHEMS Ltd, Kuopio University Hospital, Lapland Hospital District, Metropolia University of Applied Sciences, Oulu University Hospital, Oulu University of Applied Sciences, Savonia University of Applied Sciences, Tampere University, Tampere University Hospital, Turku University Hospital, Turku University of Applied Sciences |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Favorable neurological outcome | modified Rankin scale =2 (scale 0-6, 0 asymptomatic, 6 expired) | 30 days | |
Primary | Cerebral desaturation event | an absolute drop of forehead cerebral saturation = 10% from baseline for = 5 minutes | through prehospital care, approximately 60 minutes | |
Secondary | Survival | Survival | 30 days | |
Secondary | Survival | Survival | 365 days | |
Secondary | Favorable neurological outcome | modified Rankin scale =2 (scale 0-6, 0 asymptomatic, 6 expired) | 1 year | |
Secondary | 15D score | Heal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL) | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04580030 -
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
|
||
Active, not recruiting |
NCT04279054 -
Decreased Neuraxial Morphine After Cesarean Delivery
|
Early Phase 1 | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Recruiting |
NCT04099693 -
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
|
||
Terminated |
NCT02481999 -
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
|
||
Completed |
NCT04235894 -
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
|
||
Recruiting |
NCT05525104 -
The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).
|
N/A | |
Recruiting |
NCT05024084 -
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
|
Phase 4 | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03277872 -
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
|
N/A | |
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Terminated |
NCT02529696 -
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Terminated |
NCT03704285 -
Development of pk/pd Model of Propofol in Patients With Severe Burns
|
||
Recruiting |
NCT05259787 -
EP Intravenous Anesthesia in Hysteroscopy
|
Phase 4 | |
Completed |
NCT02894996 -
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
|
N/A | |
Completed |
NCT05386082 -
Anesthesia Core Quality Metrics Consensus Delphi Study
|
||
Terminated |
NCT03567928 -
Laryngeal Mask in Upper Gastrointestinal Procedures
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT04163848 -
CARbon Impact of aNesthesic Gas
|