Comparison of Endotracheal Tube Fixation Methods in Prone Position

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05643053
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 6.9
• Patients Per Site Per Month: 17.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fixation Device; Complications	Other: thomas fixation; Other: elastic band; Other: normal fixation adhesive tape; Other: reinforced adhesive tape fixation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Impact of Endotracheal Tube Fixation Methods on Tube Displacement During Pron Position
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Correct placement and subsequent fixation of the endotracheal tube in the prone patient [periopeative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA Physical Status I-III

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Medical Science, Yıldırım Beyazıt Training and Research Hospital	Ankara		Turkey

Sponsors and Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Singh G, Manikandan S, Neema PK. Endotracheal tube fixation in neurosurgical procedures operated in prone position. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):574-5. doi: 10.4103/0970-9185.86621. No abstract available.

• Responsible Party: Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital, Diskapi Yildirim Beyazit Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT05643053
• Other Study ID Numbers: 18/07/2022 142/05
• First Posted: Dec 8, 2022
• Last Update Posted: Dec 8, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Funda Atar, Diskapi Yildirim Beyazit Education and Research Hospital, Diskapi Yildirim Beyazit Education and Research Hospital: endotracheal tube fixation; fiberoptic bronchoscopy; prone position

Study Results

No Results Posted as of Dec 8, 2022