the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation (Trans)

Trans-nasal ETT Fixation

The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.

Study Overview

• Status: Completed
• Conditions: Prone Craniotomy; Endotracheal Intubation Fixation
• Intervention / Treatment: Device: SFC

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Yue Yun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• age 18-60 years old,
• ASA grade Ⅰ-Ⅱ,
• 18<BMI<24.

Exclusion criteria

• the intubation time was less than 5 hours,
• oral and facial skin damage,
• allergic to adhensive tapes,
• nasotracheal intubation,
• patients were edentulous.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M).
Experimental: Group B; The tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape.	Device: SFC; The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the distance of tube movement	It is the difference between the preoperative depth of the supine tracheal tube and the postoperative depth of the prone tracheal tube.	The participants will be followed from intubation to extubation, an expected average of 6 hours.

Collaborators and Investigators

• Sponsor: China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): December 27, 2021
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 5, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019 (Chief Medical Office (CMO) Alberta Health Services)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No