Task-based Credentialing for Medical Officers in Spinal Anesthesia
Completed · Not applicable
Conditions studied: Spinal Anesthesia, Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
In brief
Test the safety and effectiveness of training medical officers in the provision of spinal anesthesia in a rural hospital context using a non-inferiority randomized trial. The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in which patients are randomized to care by a trained MO or an anesthesiologist. The primary outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting documents "Adapted Anesthesia Safety Checklist") and effectiveness (adequate analgesia) of spinal anesthesia.
Key facts
- Study ID
- NCT04438811
- Run by
- Harvard Medical School (HMS and HSDM)
- People needed
- 486
- Starts
- 2019-03-01
- Expected to finish
- 2021-03-01
- Last updated by the study team
- 2021-04-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion criteria for MOs
- Consent to participate in practical training and clinical trial (consent process will be repeated)
- Successful completion of the theoretical and simulation training
- Be deemed safe to continue to practical training by their supervising Anesthesiologist
- Feel comfortable to proceed to practical training
- Inclusion criteria for patients
- Age 18-65
- Undergoing one of the surgeries noted in supporting document "List of surgeries for patient inclusion criteria" or otherwise deemed appropriate for spinal anesthesia as determined by surgeon and supervising anesthesiologist
- Willingness to provide informed consent
- ASA (American Society of Anesthesiology Physical Status Classification System) grades I and II
- Inclusion criteria for Consultant Anesthetists
- Anesthetist licensed to practice independently with availability to provide care at one of the selected sites
You may not qualify if…
- Exclusion criteria for MOs
- Recent suspension from clinical practice
- Due to change sites or retire before the expected end date of the trial
- Exclusion criteria for patients
- Obese (BMI > 35)
- Refusal of consent to participate in trial
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
- JSS Hospital — Ganiyari, Chhattisgarh, India
- Ashwini Hospital — Gudalur, Tamil Nadu, India
- Sittilingi Tribal Hospital — Harūr, Tamil Nadu, India
Full record on ClinicalTrials.gov
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