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

This study has been completed.
Information provided by (Responsible Party):
Senthil G. Krishna, Nationwide Children's Hospital Identifier:
First received: November 28, 2012
Last updated: February 13, 2017
Last verified: February 2017
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
Surgical Procedure, Unspecified
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:
  • Change in Intracuff Pressure [ Time Frame: 1 day ]

Enrollment: 63
Study Start Date: January 2013
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac patients
Patients undergoing cardiac surgery
Other: Cuff pressure
Measuring endotracheal tube (ETT) cuff pressure
Non-cardiac patients
Patients undergoing any surgery other than cardiac surgery
Other: Cuff pressure
Measuring endotracheal tube (ETT) cuff pressure


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgery lasting longer than 4 hours.

Inclusion Criteria:

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

Exclusion Criteria:

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Please refer to this study by its identifier: NCT01738321

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Senthil G. Krishna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Senthil G. Krishna, Assistant Clinical Professor, Nationwide Children's Hospital Identifier: NCT01738321     History of Changes
Other Study ID Numbers: IRB12-00715
Study First Received: November 28, 2012
Results First Received: February 24, 2015
Last Updated: February 13, 2017 processed this record on April 28, 2017