The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients

NCT ID: NCT06405672

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Different intubation techniques have been used in morbidly obese patients undergoing general anesthesia. No study comparing the use of endotracheal tube with or without stylet was found in literature. Thus, the investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation; Difficult or Failed Obesity, Morbid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endotracheal tube with stylet

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

Group Type OTHER

Endotracheal tube with stylet

Intervention Type PROCEDURE

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

Endotracheal tube alone

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

Group Type OTHER

Endotracheal tube alone

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endotracheal tube with stylet

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

Intervention Type PROCEDURE

Endotracheal tube alone

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -

Exclusion Criteria

Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kerem İnanoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya TRH

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kerem İnanoğlu, MD

Role: CONTACT

+902422494400

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24967423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24443105 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1/17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.