Comparison of Endotracheal Tube Fixation Methods in Prone Position

June 10, 2024 updated by: Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital

Impact of Endotracheal Tube Fixation Methods on Tube Displacement During Pron Position

In particular, prone position surgeries risk potentially life-threatening ET tube dislocation. Failure to place the plaster used for ET tube fixation correctly and adequately in this position may contaminate the patch with body fluids and loosen the weight of the breathing circuit, causing the ET tube to slip and dislodge. Adhesive tape (plaster), bandage (non-adhesive), suturing, or a commercially available tube holding device are recommended for ET tube fixation in patients operated in the prone position. In addition, the adhesive plasters used can be taped on the patient's face to the maxilla, mandible, or both. Because of the urgent and critical settings, a fast, reliable, and easy-to-use method of ET tube fixation is invaluable as it will provide clinicians with greater confidence in the stability of alternative airways and reduce complications from airway maintenance. In our clinic, different fixation methods are used according to the experience and preference of the anesthesiologist. Our study aims to compare other fixation methods using FOB to fix the position of the ET tube with an appropriate method in prone position procedures and ensure that patients have safe airway management throughout the surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Turkey
      • Ankara, Turkey
        • University of Medical Science, Yıldırım Beyazıt Training and Research Hospital

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA Physical Status I-II
  • Mallampati score I-II

Exclusion Criteria:

  • Patients who did not want to participate in the study
  • Restricted mouth opening
  • BMI ≥ 35 kg/m2
  • Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal -hernia, history of previous gastric surgery, GIS motility disorder)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thomas fixation
Other: thomas fixation
Use of the thomas tube holder for endotracheal tube fixation in patients operated in the prone position
Experimental: elastic band
Other: elastic band
Use of the elastic band for endotracheal tube fixation in patients operated in the prone position
Experimental: normal fixation adhesive tape
Other: normal fixation adhesive tape
Use of the adhesive tape for endotracheal tube fixation in patients operated in the prone position
Experimental: reinforced adhesive tape fixation
Other: reinforced adhesive tape fixation
Use of the reinforced adhesive tape fixation for endotracheal tube fixation in patients operated in the prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correct placement and subsequent fixation of the endotracheal tube in the prone patient
Time Frame: periopeative
periopeative

Collaborators and Investigators

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

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

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 (Actual)

September 1, 2022

Primary Completion (Actual)

September 9, 2023

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18/07/2022 142/05

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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