N/A
N=84
Endotracheal Tube Intracuff Pressure and Leak
Otolaryngological Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02376179 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Changes in the Intracuff Pressure — 3 cmH2O
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cuffed ETT (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Kris Jatana
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Intracuff Pressure |
3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02376179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.