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Clinical Trials/NCT02640248
NCT02640248
Withdrawn
Not Applicable

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

Kris Jatana1 site in 1 countryNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otolaryngological Surgery
Sponsor
Kris Jatana
Locations
1
Primary Endpoint
Changes in intracuff pressure
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
December 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kris Jatana
Responsible Party
Sponsor Investigator
Principal Investigator

Kris Jatana

Ears Nose Throat 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 intracuff pressure

Time Frame: during time of surgery

Changes in intracuff pressure of cuffed ETT related to the position of the patient's head and retractor placement.

Study Sites (1)

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