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Clinical Trials/NCT02376179
NCT02376179
Completed
Not Applicable

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

Kris Jatana1 site in 1 country84 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otolaryngological Surgery
Sponsor
Kris Jatana
Enrollment
84
Locations
1
Primary Endpoint
Changes in the Intracuff Pressure
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
June 1, 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kris Jatana
Responsible Party
Sponsor Investigator
Principal Investigator

Kris Jatana

ENT Surgeon

Nationwide Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in the Intracuff Pressure

Time Frame: during time of surgery

Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.

Study Sites (1)

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