An interventional study of delivery of the spinal anesthetic by a trained medical officer and delivery of spinal anesthetic by a consultant anesthetist in Spinal Anesthesia and Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care, sponsored by Harvard Medical School (HMS and HSDM). Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Harvard Medical School (HMS and HSDM) · Not applicable, Interventional, and Treatment
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.
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) demonstrated that Africa and South Asia, home to over a third of the global population, lay claim to just 12% of surgeons, anesthesiologists and obstetricians. This workforce shortage may be particularly severe for anesthesia care given that anesthesiologist make up less than 20% of surgical care providers globally. In a series of qualitative interviews, providers across three continents noted that in rural and under-resourced areas, it was unlikely that there was a surgeon and an anesthesiologist in the same place.
In India, the concerns of under-provision of human resources in the rural area are especially severe. The Lancet commission on Global Surgery estimates that while 68% of Indians live in rural areas, only 22% of the health care workforce does. For specialist services, which are even more urbanized, the disparity is likely greater. The result is that, in South Asia, 95% of people are estimated to lack access to safe, affordable and timely surgical care.
In India, which is home to nearly 400 medical schools, it may be posited that the country is well positioned to close this gap. However, the number of postgraduate training seats - 14,000 countrywide - are entirely insufficient for the 50,000 doctors that graduate each year. With only 1500 postgraduate training seats for anesthesia, a graduate who may otherwise aspire to train in anesthesia instead remains generalist MO or seeks training elsewhere. The World Health Organization suggests that a presence of anesthesiologists in rural India may be so scarce it is "non-existent.". It has also been estimated that 43% of the Indian population lives more than 50km from their nearest health center, 76% of which do not have an anesthesiologist.
The result of these human resource limitations, is that rural Indian surgeons often administer anesthesia for their patient prior to performing necessary surgeries or medical officers with only ad hoc training provide anesthesia care. The de facto standard of care in rural India, ends up being the provision of anesthesia by a surgeon or untrained medical officer. While advocacy towards increasing post-graduate education must continue, it is also clear that interim measures are needed to improve upon current baseline practices.
One such measure suggested by the Disease Control Priorities 3 (DCP3), the LCoGS, and others is the concept of "task-based credentialing." In this model of credentialing, physicians are trained and credentialed in a limited set of procedures. Task sharing - a process by which non-specialists take on whole-sale the tasks typically performed by a specialist - is prevalent in the provision of anesthesia care worldwide. However, a recent meta-analysis evaluated outcomes for task-sharing in anesthesia in 15 LMIC and found that administration of anesthesia by a non-physician was a risk-factor for maternal mortality. To mitigate these concerns, task-based credentialing focuses on the training of non-specialist medical officers in a discrete, well-defined task and includes training to deal with the possible complications. This task-based training would serve as an improvement on the de facto standard of care in rural India by providing specific training in place of ad hoc learning.
The provision of spinal anesthesia is thought to be well-suited for this form of training. The procedure involves the injection of a local anesthetic agent into the subarachnoid space. This allows for analgesia and anesthesia below the level of injection. This procedure is widely used in general surgery, obstetric surgery, and orthopedic surgery. Moreover, the use of spinal anesthesia is particularly well-adapted to rural care as it is less expensive than general anesthesia and has a lower requirement of infrastructure and disposables when compared to general anesthesia.
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.
Harvard Medical School (HMS and HSDM) is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for MOs
Inclusion criteria for patients
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
Inclusion criteria for Consultant Anesthetists
Exclusion Criteria:
Exclusion criteria for MOs
Exclusion criteria for patients
Patients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist
Other: delivery of spinal anesthetic by a consultant anesthetist
Patients randomized to this arm will receive their spinal anesthetic from a medical officer. There will be a consultant anesthetist immediately available if needed but they will not be a direct participant in this arm. Any involvement by the consultant will result in the label of failure for this patient.
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.
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.
Successful delivery of spinal anaesthesia
Delivery of spinal anaesthesia into the intrathecal space with three or less attempts and no intra-operative conversion to general anaesthesia due to spinal failure
Time frame: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)
Post-operative Complications
Incidence of post-dural puncture headache, epidural haematoma, spinal abscess and neurological deficit
Time frame: Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Patient experience measures
Patient reported experience measures of clinical care and pain
Time frame: Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively
Intraoperative Complications
The incidence of hypotension, bradycardia, high spinal, apnoea and hypoxia
Time frame: Assessed intraoperatively during surgical procedure
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Harvard Medical School (HMS and HSDM)