NCT05093595

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 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

First Submitted

Initial submission to the registry

October 12, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

March 8, 2022

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

October 12, 2021

Last Update Submit

March 5, 2022

Conditions

Prone CraniotomyEndotracheal Intubation Fixation

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Group A

NO INTERVENTION

The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M).

Group B

EXPERIMENTAL

The tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape.

Device: SFC

Interventions

SFCDEVICE

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 .

Group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yue Yun

Shenyang, Liaoning, 110001, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Doctor

Study Record Dates

First Submitted

October 12, 2021

First Posted

October 26, 2021

Study Start

October 27, 2021

Primary Completion

December 27, 2021

Study Completion

January 25, 2022

Last Updated

March 8, 2022

Record last verified: 2021-10

Locations

CN(1)