NCT06405672

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 8, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 30, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

different intubation techniquesendotracheal tubeobesitystylet

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

OTHER

The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy

Procedure: Endotracheal tube with stylet

Endotracheal tube alone

OTHER

The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy

Procedure: Endotracheal tube alone

Interventions

The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy

Endotracheal tube with stylet

The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy

Endotracheal tube alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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: 24967423BACKGROUND
  • Nicholson 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

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kerem İnanoğlu, MD

    Antalya TRH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerem İnanoğlu, MD

CONTACT

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