Status:
COMPLETED
Task-based Credentialing for Medical Officers in Spinal Anesthesia
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Collaborating Sponsors:
Ashwini Health System, Gudalur, India
Harvard Center for Global Health, Dubai
Conditions:
Spinal Anesthesia
Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
The vast majority of the world is without access to surgical and anesthesia care, and a severe workforce shortage is a major contributing factor. The Lancet Commission on Global Surgery (LCoGS) demons...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT04438811
Start Date
March 1 2019
End Date
March 1 2021
Last Update
April 29 2021
Active Locations (4)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
JSS Hospital
Ganiyari, Chhattisgarh, India
3
Ashwini Hospital
Gudalur, Tamil Nadu, India
4
Sittilingi Tribal Hospital
Harūr, Tamil Nadu, India