Spinal AnesthesiaNCT04438811
Task-based Credentialing for Medical Officers in Spinal Anesthesia
A study testing delivery of the spinal anesthetic by a trained medical officer and delivery of spinal anesthetic by a consultant anesthetist in people with Spinal Anesthesia and Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care, run by Harvard Medical School (HMS and HSDM) at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
- What is being tested?
- delivery of the spinal anesthetic by a trained medical officer and delivery of spinal anesthetic by a consultant anesthetist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Mar 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- Willingness to provide informed consent
- ASA (American Society of Anesthesiology Physical Status Classification System) grades I and II
- Anesthetist licensed to practice independently with availability to provide care at one of the selected sites
Who cannot join
- Recent suspension from clinical practice
- Due to change sites or retire before the expected end date of the trial
- Obese (BMI > 35)
- Refusal of consent to participate in trial
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
India3 sites
JSS Hospital
Ganiyari, Chhattisgarh
Ashwini Hospital
Gudalur, Tamil Nadu
Sittilingi Tribal Hospital
Harūr, Tamil Nadu
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Task-based Credentialing for Medical Officers in Spinal Anesthesia: An Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals Curriculum Training of Medical Officers
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.
Read the 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) 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.
- Conditions
- Spinal Anesthesia, Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
- Being tested
- delivery of the spinal anesthetic by a trained medical officer, delivery of spinal anesthetic by a consultant anesthetist
- Keywords
- global health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delivery of the spinal anesthetic by a trained medical officerOther
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.
delivery of spinal anesthetic by a consultant anesthetistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Consultant Anesthetist | Other | Patients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist Receives: Other: delivery of spinal anesthetic by a consultant anesthetist |
| Medical Officer | Other | 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. Receives: Other: delivery of the spinal anesthetic by a trained medical officer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)
Secondary outcomes (3)
Post-operative Complications
Incidence of post-dural puncture headache, epidural haematoma, spinal abscess and neurological deficit
Measured: 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
Measured: 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
Measured: Assessed intraoperatively during surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Mar 2019
- Primary completion10 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-inferiority, randomized trial. Patients will be randomized to receive a protocolized spinal anesthetic from a consultant anesthetist or a trained medical officer. Failure rates and need for rescue will be assessed as primary outcomes.
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Ashwini Health System, Gudalur, India, Harvard Center for Global Health, Dubai, Boston Children's Hospital, Program in Global Surgery and Social Change, Harvard Medical School
- Responsible party
- Principal investigator, Craig McClain, Harvard Medical School (HMS and HSDM)
- Investigators
- Craig D McClain, MD, MPH, Principal investigator, Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438811
- Sponsor's protocol ID
- IRB17-0624
- Status last verified
- Apr 2021
- First submitted
- 8 Jun 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X. Epub 2015 Apr 26. No abstract available.
PubMed 25924834Grimes CE, Bowman KG, Dodgion CM, Lavy CB. Systematic review of barriers to surgical care in low-income and middle-income countries. World J Surg. 2011 May;35(5):941-50. doi: 10.1007/s00268-011-1010-1.
PubMed 21360305Hoyler M, Finlayson SR, McClain CD, Meara JG, Hagander L. Shortage of doctors, shortage of data: a review of the global surgery, obstetrics, and anesthesia workforce literature. World J Surg. 2014 Feb;38(2):269-80. doi: 10.1007/s00268-013-2324-y.
PubMed 24218153Bergstrom S, McPake B, Pereira C, Dovlo D. Workforce Innovations to Expand the Capacity for Surgical Services. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2015 Apr 2. Chapter 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK333504/
PubMed 26741003Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available.
PubMed 25926323Dubowitz G, Detlefs S, McQueen KA. Global anesthesia workforce crisis: a preliminary survey revealing shortages contributing to undesirable outcomes and unsafe practices. World J Surg. 2010 Mar;34(3):438-44. doi: 10.1007/s00268-009-0229-6.
PubMed 19795163Ng-Kamstra JS, Greenberg SLM, Abdullah F, Amado V, Anderson GA, Cossa M, Costas-Chavarri A, Davies J, Debas HT, Dyer GSM, Erdene S, Farmer PE, Gaumnitz A, Hagander L, Haider A, Leather AJM, Lin Y, Marten R, Marvin JT, McClain CD, Meara JG, Mehes M, Mock C, Mukhopadhyay S, Orgoi S, Prestero T, Price RR, Raykar NP, Riesel JN, Riviello R, Rudy SM, Saluja S, Sullivan R, Tarpley JL, Taylor RH, Telemaque LF, Toma G, Varghese A, Walker M, Yamey G, Shrime MG. Global Surgery 2030: a roadmap for high income country actors. BMJ Glob Health. 2016 Apr 6;1(1):e000011. doi: 10.1136/bmjgh-2015-000011. eCollection 2016.
PubMed 28588908Raykar NP, Yorlets RR, Liu C, Greenberg SL, Kotagal M, Goldman R, Roy N, Meara JG, Gillies RD. A qualitative study exploring contextual challenges to surgical care provision in 21 LMICs. Lancet. 2015 Apr 27;385 Suppl 2(Suppl 2):S15. doi: 10.1016/S0140-6736(15)60810-8. Epub 2015 Apr 26.
PubMed 26313061Alkire BC, Raykar NP, Shrime MG, Weiser TG, Bickler SW, Rose JA, Nutt CT, Greenberg SL, Kotagal M, Riesel JN, Esquivel M, Uribe-Leitz T, Molina G, Roy N, Meara JG, Farmer PE. Global access to surgical care: a modelling study. Lancet Glob Health. 2015 Jun;3(6):e316-23. doi: 10.1016/S2214-109X(15)70115-4. Epub 2015 Apr 27.
PubMed 25926087MUZAFFARNAGAR, I. Special Report: Why India's medical schools are plagued with fraud. Available from: http://www.reuters.com/article/us-india-medicine-education- specialrepor-idUSKBN0OW1NM20150617.
Shetty, D., Reform medical education, transform healthcare, in The Times of India. 2015.
Cherian M, Choo S, Wilson I, Noel L, Sheikh M, Dayrit M, Groth S. Building and retaining the neglected anaesthesia health workforce: is it crucial for health systems strengthening through primary health care? Bull World Health Organ. 2010 Aug 1;88(8):637-9. doi: 10.2471/BLT.09.072371. Epub 2010 May 10. No abstract available.
PubMed 20680130Dare AJ, Ng-Kamstra JS, Patra J, Fu SH, Rodriguez PS, Hsiao M, Jotkar RM, Thakur JS, Sheth J, Jha P; Million Death Study Collaborators. Deaths from acute abdominal conditions and geographical access to surgical care in India: a nationally representative spatial analysis. Lancet Glob Health. 2015 Oct;3(10):e646-53. doi: 10.1016/S2214-109X(15)00079-0. Epub 2015 Aug 13.
PubMed 26278186Jamison DT, Alwan A, Mock CN, Nugent R, Watkins D, Adeyi O, Anand S, Atun R, Bertozzi S, Bhutta Z, Binagwaho A, Black R, Blecher M, Bloom BR, Brouwer E, Bundy DAP, Chisholm D, Cieza A, Cullen M, Danforth K, de Silva N, Debas HT, Donkor P, Dua T, Fleming KA, Gallivan M, Garcia PJ, Gawande A, Gaziano T, Gelband H, Glass R, Glassman A, Gray G, Habte D, Holmes KK, Horton S, Hutton G, Jha P, Knaul FM, Kobusingye O, Krakauer EL, Kruk ME, Lachmann P, Laxminarayan R, Levin C, Looi LM, Madhav N, Mahmoud A, Mbanya JC, Measham A, Medina-Mora ME, Medlin C, Mills A, Mills JA, Montoya J, Norheim O, Olson Z, Omokhodion F, Oppenheim B, Ord T, Patel V, Patton GC, Peabody J, Prabhakaran D, Qi J, Reynolds T, Ruacan S, Sankaranarayanan R, Sepulveda J, Skolnik R, Smith KR, Temmerman M, Tollman S, Verguet S, Walker DG, Walker N, Wu Y, Zhao K. Universal health coverage and intersectoral action for health: key messages from Disease Control Priorities, 3rd edition. Lancet. 2018 Mar 17;391(10125):1108-1120. doi: 10.1016/S0140-6736(17)32906-9. Epub 2017 Nov 25.
PubMed 29179954Gnanaraj J, Jason LY, Khiangte H. High quality surgical care at low cost: the diagnostic camp model of Burrows Memorial Christian Hospital (BMCH). Indian J Surg. 2007 Dec;69(6):243-7. doi: 10.1007/s12262-007-0034-0. Epub 2008 Jan 28.
PubMed 23132995
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-based Credentialing for Medical Officers in Spinal Anesthesia: An Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals Curriculum Training of Medical Officers
- ClinicalTrials.gov ID
- NCT04438811
- Acronym / sponsor ID
- IRB17-0624
- Conditions
- Spinal Anesthesia, Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care
- Keywords
- global health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Ashwini Health System, Gudalur, India, Harvard Center for Global Health, Dubai, Boston Children's Hospital, Program in Global Surgery and Social Change, Harvard Medical School
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-inferiority, randomized trial. Patients will be randomized to receive a protocolized spinal anesthetic from a consultant anesthetist or a trained medical officer. Failure rates and need for rescue will be assessed as primary outcomes.
| Arm | Type | Receives |
|---|---|---|
| Consultant Anesthetist | Other | Other: delivery of spinal anesthetic by a consultant anesthetistPatients who are randomized to this arm will receive their spinal anesthesia froma consultant anesthetist |
| Medical Officer | Other | Other: delivery of the spinal anesthetic by a trained medical officerPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Age 18-65
Key exclusion criteria (4 listed)
- Recent suspension from clinical practice
- Due to change sites or retire before the expected end date of the trial
- Obese (BMI > 35)
- Refusal of consent to participate in trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delivery of the spinal anesthetic by a trained medical officerThe 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 | Medical Officer |
| delivery of spinal anesthetic by a consultant anesthetistThe 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 | Consultant Anesthetist |
Primary outcome
Successful delivery of spinal anaesthesia
Time frame: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)
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
3 secondary outcomes
Post-operative Complications
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
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
Time frame: Assessed intraoperatively during surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 25924834Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X. Epub 2015 Apr 26. No abstract available.
- Background: PubMed 21360305Grimes CE, Bowman KG, Dodgion CM, Lavy CB. Systematic review of barriers to surgical care in low-income and middle-income countries. World J Surg. 2011 May;35(5):941-50. doi: 10.1007/s00268-011-1010-1.
- Background: PubMed 24218153Hoyler M, Finlayson SR, McClain CD, Meara JG, Hagander L. Shortage of doctors, shortage of data: a review of the global surgery, obstetrics, and anesthesia workforce literature. World J Surg. 2014 Feb;38(2):269-80. doi: 10.1007/s00268-013-2324-y.
- Background: PubMed 26741003Bergstrom S, McPake B, Pereira C, Dovlo D. Workforce Innovations to Expand the Capacity for Surgical Services. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2015 Apr 2. Chapter 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK333504/
- Background: PubMed 25926323Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available.
- Background: PubMed 19795163Dubowitz G, Detlefs S, McQueen KA. Global anesthesia workforce crisis: a preliminary survey revealing shortages contributing to undesirable outcomes and unsafe practices. World J Surg. 2010 Mar;34(3):438-44. doi: 10.1007/s00268-009-0229-6.
- Background: PubMed 28588908Ng-Kamstra JS, Greenberg SLM, Abdullah F, Amado V, Anderson GA, Cossa M, Costas-Chavarri A, Davies J, Debas HT, Dyer GSM, Erdene S, Farmer PE, Gaumnitz A, Hagander L, Haider A, Leather AJM, Lin Y, Marten R, Marvin JT, McClain CD, Meara JG, Mehes M, Mock C, Mukhopadhyay S, Orgoi S, Prestero T, Price RR, Raykar NP, Riesel JN, Riviello R, Rudy SM, Saluja S, Sullivan R, Tarpley JL, Taylor RH, Telemaque LF, Toma G, Varghese A, Walker M, Yamey G, Shrime MG. Global Surgery 2030: a roadmap for high income country actors. BMJ Glob Health. 2016 Apr 6;1(1):e000011. doi: 10.1136/bmjgh-2015-000011. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig D McClain, MD, MPH principal investigator
Boston Children's Hospital, Harvard Medical School, Program in Global Surgery and Social Change
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delivery of the spinal anesthetic by a trained medical officer and delivery of spinal anesthetic by a consultant anesthetist in people with Spinal Anesthesia and Task Sharing in Anesthetic Delivery in Areas With Limited Access to Care, run by Harvard Medical School (HMS and HSDM) at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful delivery of spinal anaesthesia (time frame: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438811, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.