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Endotracheal Tube Intracuff Pressure and Leak

NCT ID: NCT02376179

Last Updated: 2019-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Otolaryngological Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cuffed ETT

Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.

Cuffed ETT

Intervention Type DEVICE

Interventions

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Cuffed ETT

Intervention Type DEVICE

Other Intervention Names

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Kimberly Clark Microcuff ETT

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kris Jatana

OTHER

Sponsor Role lead

Responsible Party

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Kris Jatana

ENT Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26956620 (View on PubMed)

Other Identifiers

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IRB13-00613

Identifier Type: -

Identifier Source: org_study_id