Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592313
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Difficult Airway in the Bariatric Patient the BARINTUBE Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Difficult Airway in the Bariatric Patient the BARINTUBE Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
BARINTUBE
Brief Summary:
Background Difficult airway in bariatric patients presents significant challenges during anesthesia impacting patient safety and surgical outcomes This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery
Materials and Methods This prospective observational cohort study will be conducted in a single center Patients over 18 years with a BMI 30 kgm2 undergoing bariatric surgery and requiring intubation will be included Data will be collected on patient demographics clinical characteristics and intubation outcomes The primary outcome is the occurrence of difficult airway defined by specific criteria including intubation difficulty and the need for alternative airway management techniques Secondary outcomes include complications related to airway management and overall surgical outcomes A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3
Conclusions Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions
Materials and Methods This prospective observational cohort study will be conducted in a single center Patients over 18 years with a BMI 30 kgm2 undergoing bariatric surgery and requiring intubation will be included Data will be collected on patient demographics clinical characteristics and intubation outcomes The primary outcome is the occurrence of difficult airway defined by specific criteria including intubation difficulty and the need for alternative airway management techniques Secondary outcomes include complications related to airway management and overall surgical outcomes A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3
Conclusions Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions
Detailed Description:
None
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