Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endotracheal Tube Intracuff Pressure and Leak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376179
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : January 16, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kris Jatana, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Otolaryngological Surgery Device: Cuffed ETT

Layout table for study information
Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endotracheal Tube Intracuff Pressure and Leak Around the Cuff During Retractor Placement for Tonsillectomy and/or Adenoidectomy
Study Start Date : August 2014
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Group/Cohort Intervention/treatment
Cuffed ETT
Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Device: Cuffed ETT
Other Name: Kimberly Clark Microcuff ETT




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376179


Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Kris Jatana
Publications of Results:
Layout table for additonal information
Responsible Party: Kris Jatana, ENT Surgeon, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02376179    
Other Study ID Numbers: IRB13-00613
First Posted: March 3, 2015    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: December 11, 2019
Last Verified: December 2019