Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Senthil Gopalakrishnan, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01738321
First received: November 28, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

To date, there are no data in the literature regarding changes in the intracuff pressure during prolonged surgical procedures. It is possible that the pressure will increase over time related to gas expansion during equilibration to body temperature. If this is the case, these patients may be at risk for tracheal damage. This is a prospective study to evaluate the changes in intracuff pressure over time during prolonged surgical procedures.


Condition Intervention
Surgeries Greater Than 4 Hours.
Other: Cuff pressure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Cuff pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical patients Other: Cuff pressure
Measuring endotracheal tube (ETT) cuff pressure

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing surgery lasting longer than 4 hours.

Criteria

Inclusion Criteria:

  • Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours.

Exclusion Criteria:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738321

Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Senthil Gopalakrishnan
  More Information

No publications provided

Responsible Party: Senthil Gopalakrishnan, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01738321     History of Changes
Other Study ID Numbers: IRB12-00715
Study First Received: November 28, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014