CClinicalTrials.gg
CompletedNCT01851317Updated Dec 13, 2023

The Relationship Between Patients' Head Position and ETT Intracuff Pressure

An observational study in Patients Undergoing ENT Surgery With Cuffed ETT, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Nationwide Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
Up to 17 Years
Sex
All
01

Study summary

This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.

Read the detailed description

There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.

02

Conditions studied

  • Patients Undergoing ENT Surgery With Cuffed ETT
03

In context

Lead sponsor

Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing otolaryngological surgery with cuffed endotracheal tube

Inclusion criteria

  • Age less than 18 years
  • Undergoing otolaryngological surgery with endotracheal intubation

Exclusion criteria

Exclusion Criteria:

  • Patient who is intubated with an uncuffed endotracheal tube
  • Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Intracuff pressure

    Procedure/Surgery: Cuffed endotracheal tube

06

What researchers measure

Primary outcomes

  1. Endotracheal tube intracuff pressure

    An intracuff pressure ≥ 30 cmH2O may compromise the tracheal mucosal perfusion and result in tracheal damage.

    Time frame: 1 day

07

Study locations

1 site
  • Nationwide Children's
    Columbus, Ohio 43205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01851317
Lead sponsor
Nationwide Children's Hospital
Responsible party
Sponsor
First posted
May 10, 2013
Start date
Apr 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Dec 13, 2023

Study contacts

Hiromi Kako, M.D.
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion