Comparison of Endotracheal Tube Fixation Methods in Prone Position

NCT ID: NCT05643053

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-06-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fixation Device; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

thomas fixation

Group Type EXPERIMENTAL

thomas fixation

Intervention Type OTHER

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

elastic band

Group Type EXPERIMENTAL

elastic band

Intervention Type OTHER

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

normal fixation adhesive tape

Group Type EXPERIMENTAL

normal fixation adhesive tape

Intervention Type OTHER

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

reinforced adhesive tape fixation

Group Type EXPERIMENTAL

reinforced adhesive tape fixation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

thomas fixation

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

Intervention Type OTHER

elastic band

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

Intervention Type OTHER

normal fixation adhesive tape

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

Intervention Type OTHER

reinforced adhesive tape fixation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Funda Atar

Diskapi Yildirim Beyazit Education and Research Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Medical Science, Yıldırım Beyazıt Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22096310 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18/07/2022 142/05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.