The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients

May 6, 2024 updated by: Antalya Training and Research Hospital

Comparison of Using an Endotracheal Tube With Stylet Versus an Endotracheal Tube Alone in Morbidly Obese Patients

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Endotracheal tube with stylet
The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
Procedure: Endotracheal tube with stylet
The obese patients who will be intubated with stylet in laparoscopic sleeve gastrectomy
Other: Endotracheal tube alone
The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy
Procedure: Endotracheal tube alone
The obese patients who will be intubated without stylet in laparoscopic sleeve gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: through study completion, an average of 6 months
from handling laryngoscope to first vision of end-tidal CO2 waveform
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation success
Time Frame: through study completion, an average of 6 months
success or failure of first intubation attempt
through study completion, an average of 6 months
complications
Time Frame: through study completion, an average of 6 months
Undesirable complications such as laryngospazm, hoarseness will be recorded at postoperative period
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Principal Investigator: Kerem İnanoğlu, MD, Antalya TRH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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