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OpenTrials
Completed

NCT Number: NCT02376179

Endotracheal Tube Intracuff Pressure and Leak

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cuffed ETT

Device

Other names: Kimberly Clark Microcuff ETT

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kris Jatana

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2015
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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