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

NCT02640248 | Withdrawn

• 1 other identifier: IRB15-00902
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otolaryngological Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cuff ETT

Device: Cuff ETT

Interventions

Cuff ETT DEVICE

Cuff ETT

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kris Jatana: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ears Nose Throat Surgeon

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 22, 2021

Record last verified: 2019-11

Locations

US (1)