Monitoring Changes in Endotracheal Tube Cuff Pressure During Laparoscopic Bariatric Surgery

December 13, 2024 updated by: Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
This prospective observational cohort study was designed to assess the relationship between ETT cuff pressures and airway pressures in obese patients undergoing laparoscopic bariatric surgery. We hypothesized that the ETT cuff pressures will rise in direct relationship to increases in the peak and mean airway pressures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

28

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

Study Locations

  • Turkey
    • Di̇yarbakir
      • Kayapinar, Di̇yarbakir, Turkey

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

28

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) risk indicators I-III manage to undergo Laparoscopic bariatric surgery between the ages of 18-70

Exclusion Criteria:

  • Patients with drug allergies, chronic pain, long-term opioid use, history of psychiatric illness, and need for emergency surgery were excluded from the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETT cuff pressure
Time Frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
ETT cuff pressure
1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak airway pressures
Time Frame: 1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation
Peak airway pressures
1-immediately after intubation; 2-after intraperitoneal insufflation; 3-after the position is given 4-after peritoneal exsufflation

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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 (Actual)

December 10, 2024

Primary Completion (Estimated)

January 10, 2025

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HTONER

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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