Task-based Credentialing for Medical Officers in Spinal Anesthesia

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 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.

Conditions

• Spinal Anesthesia
• Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care

Interventions

OTHER

delivery of the spinal anesthetic by a trained medical officer

The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.

OTHER

delivery of spinal anesthetic by a consultant anesthetist

The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.

Sponsors & Collaborators

• Ashwini Health System, Gudalur, India

  collaborator UNKNOWN

• Harvard Center for Global Health, Dubai

  collaborator UNKNOWN

• Boston Children's Hospital

  collaborator OTHER

• Program in Global Surgery and Social Change, Harvard Medical School

  collaborator UNKNOWN

• Harvard Medical School (HMS and HSDM)

  lead OTHER

Principal Investigators

• Craig D McClain, MD, MPH · Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2021-01-10

Completion

2021-03-01

Countries

• United States
• India

Study Locations