The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients
Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2024
CompletedStudy Start
First participant enrolled
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedMay 8, 2024
April 1, 2024
4 months
April 30, 2024
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intubation time
from handling laryngoscope to first vision of end-tidal CO2 waveform
through study completion, an average of 6 months
Secondary Outcomes (2)
Intubation success
through study completion, an average of 6 months
complications
through study completion, an average of 6 months
Study Arms (2)
Endotracheal tube with stylet
OTHERThe obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
Endotracheal tube alone
OTHERThe obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy
Interventions
The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy
Eligibility Criteria
You may qualify if:
- Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -
You may not qualify if:
- Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Gaszynski T, Pietrzyk M, Szewczyk T, Gaszynska E. A comparison of performance of endotracheal intubation using the Levitan FPS optical stylet or Lary-Flex videolaryngoscope in morbidly obese patients. ScientificWorldJournal. 2014;2014:207591. doi: 10.1155/2014/207591. Epub 2014 May 20.
PMID: 24967423BACKGROUNDNicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;2014(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.
PMID: 24443105BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerem İnanoğlu, MD
Antalya TRH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 8, 2024
Study Start
April 30, 2024
Primary Completion
August 30, 2024
Study Completion
September 30, 2024
Last Updated
May 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share