Comparison of Endotracheal Tube Fixation Methods in Prone Position

Fixation Device; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05643053
• Other study ID #: 18/07/2022 142/05
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 10, 2024

Study information

• Verified date: June 2024
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 10, 2024
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fixation Device; Complications

Intervention

Other:
• thomas fixation
Use of the thomas tube holder for endotracheal tube fixation in patients operated in the prone position
• elastic band
Use of the elastic band for endotracheal tube fixation in patients operated in the prone position
• normal fixation adhesive tape
Use of the adhesive tape for endotracheal tube fixation in patients operated in the prone position
• reinforced adhesive tape fixation
Use of the reinforced adhesive tape fixation for endotracheal tube fixation in patients operated in the prone position

Locations

Country	Name	City	State
Turkey	University of Medical Science, Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct placement and subsequent fixation of the endotracheal tube in the prone patient		periopeative