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

Otolaryngological Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02640248
• Other study ID #: IRB15-00902
• Status: Withdrawn
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: November 2019
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Otolaryngological Surgery

Intervention

Device:
• Cuff ETT

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kris Jatana

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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