The Relationship Between Patients' Head Position and ETT Intracuff Pressure

The Relationship Between Patients' Position and Endotracheal Tube Intracuff Pressure in Pediatric Population

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

Study Overview

• Status: Completed
• Conditions: Patients Undergoing ENT Surgery With Cuffed ETT

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing otolaryngological surgery with cuffed endotracheal tube

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Intracuff pressure; Procedure/Surgery: Cuffed endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotracheal tube intracuff pressure	An intracuff pressure ≥ 30 cmH2O may compromise the tracheal mucosal perfusion and result in tracheal damage.	1 day

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Hiromi Kako, M.D., Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimated): May 10, 2013

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB13-00243