Endotracheal Tube Intracuff Pressure and Leak
1 other identifier
observational
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
January 16, 2019
CompletedDecember 11, 2019
December 1, 2019
1.8 years
February 24, 2015
July 24, 2018
December 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Cuffed ETT
Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Interventions
Eligibility Criteria
Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
You may qualify if:
- Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kris Jatanalead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related 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 Mar 9.
PMID: 26956620RESULT
Results Point of Contact
- Title
- Kris Jatana, MD
- Organization
- Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- ENT Surgeon
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 3, 2015
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 11, 2019
Results First Posted
January 16, 2019
Record last verified: 2019-12