Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557746
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Coca-Cola vs Oxygen for Fatigue Management in Tibet Surgeons
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coca-Cola Versus Supplemental Oxygen on Fatigue Management in Tibet Surgeons
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMETS
Brief Summary:
The study will be conducted among surgeons in Tibet comparing the effects of Coca-Cola and supplemental oxygen on fatigue alleviation Additionally pre-planned subgroup analyses will examine the potential differences in effectiveness between Tibetan surgeons who have long lived in high-altitude areas and Han surgeons who work in these areas for shorter periods The investigators hypothesize that for Tibetan surgeons Coca-Cola will be more effective in alleviating fatigue while for Han Chinese surgeons supplemental oxygen will be more effective
Detailed Description:
Fatigue in surgeons can result in reduced concentration and muscle strength compromising the safety of surgical procedures particularly in high-altitude areas In Tibet surgeons often drink cola or inhale oxygen during operations as these are believed to help alleviate fatigue This study aims to evaluate the effects of Coca-Cola and supplemental oxygen in relieving fatigue among surgeons in Tibet and to investigate whether these effects vary based on the ethnicity of the doctors
This study employs a stepped-wedge cluster randomized controlled trial design recruiting 22 surgeons k22 Each doctor is scheduled to perform 24 surgeries and evaluated At the beginning of the trial all surgeons will drink cola The supplemental oxygen will be administered in a random sequence to all participants until each has received the intervention The primary outcome measure is the change in concentration performance scores before and after surgery ΔCP The secondary outcome measure is the change in maximum voluntary hand grip strength before and after surgery ΔMVC The study follows the intention-to-treat principle including all subjects who have entered the randomization sequence in the analysis of the primary outcomes
This study employs a stepped-wedge cluster randomized controlled trial design recruiting 22 surgeons k22 Each doctor is scheduled to perform 24 surgeries and evaluated At the beginning of the trial all surgeons will drink cola The supplemental oxygen will be administered in a random sequence to all participants until each has received the intervention The primary outcome measure is the change in concentration performance scores before and after surgery ΔCP The secondary outcome measure is the change in maximum voluntary hand grip strength before and after surgery ΔMVC The study follows the intention-to-treat principle including all subjects who have entered the randomization sequence in the analysis of the primary outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None