NCT05643053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

November 23, 2022

Last Update Submit

June 10, 2024

Conditions

Fixation Device; Complications

Keywords

endotracheal tube fixationfiberoptic bronchoscopyprone position

Outcome Measures

Primary Outcomes (1)

  • Correct placement and subsequent fixation of the endotracheal tube in the prone patient

    periopeative

Study Arms (4)

thomas fixation

EXPERIMENTAL
Other: thomas fixation

elastic band

EXPERIMENTAL
Other: elastic band

normal fixation adhesive tape

EXPERIMENTAL
Other: normal fixation adhesive tape

reinforced adhesive tape fixation

EXPERIMENTAL
Other: reinforced adhesive tape fixation

Interventions

thomas fixationOTHER

Use of the thomas tube holder for endotracheal tube fixation in patients operated in the prone position

thomas fixation
elastic bandOTHER

Use of the elastic band for endotracheal tube fixation in patients operated in the prone position

elastic band
normal fixation adhesive tapeOTHER

Use of the adhesive tape for endotracheal tube fixation in patients operated in the prone position

normal fixation adhesive tape
reinforced adhesive tape fixationOTHER

Use of the reinforced adhesive tape fixation for endotracheal tube fixation in patients operated in the prone position

reinforced adhesive tape fixation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Science, Yıldırım Beyazıt Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related 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.

    PMID: 22096310BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diskapi Yildirim Beyazit Education and Research Hospital

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 8, 2022

Study Start

September 1, 2022

Primary Completion

September 9, 2023

Study Completion

June 10, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)