Endotracheal Tube Intracuff Pressure and Leak

Otolaryngological Surgery Clinical Trial

Official title:

Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376179
• Other study ID #: IRB13-00613
• Status: Completed
• Start date: August 2014
• Est. completion date: June 1, 2016

Study information

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

Clinical Trial Summary

We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We 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. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• 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:
• Cuffed 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, 

References & Publications (1)

Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Intracuff Pressure	Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.	during time of surgery