Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Adenotonsillectomy

The investigators have devised a simple method to continuously measure the CP using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. The investigators have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery and also measure the oxygen concentration in the oropharynx to determine the potential risk of an airway fire.

Study Overview

• Status: Withdrawn
• Conditions: Otolaryngological Surgery
• Intervention / Treatment: Device: Cuff ETT

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation

Description

Inclusion Criteria:

• Less than 18 years of age, 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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cuff ETT	Device: Cuff ETT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in intracuff pressure	Changes in intracuff pressure of cuffed ETT related to the position of the patient's head and retractor placement.	during time of surgery

Collaborators and Investigators

• Sponsor: Kris Jatana

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB15-00902