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

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: NCT01738321
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : July 10, 2015
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Surgical Procedure, Unspecified Other: Cuff pressure

Study Design

Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Primary Completion Date : December 2014
Study Completion Date : January 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Change in Intracuff Pressure [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

Contacts and Locations

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): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senthil G. Krishna, Assistant Clinical Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01738321     History of Changes
Other Study ID Numbers: IRB12-00715
First Posted: November 30, 2012    Key Record Dates
Results First Posted: July 10, 2015
Last Update Posted: March 21, 2017
Last Verified: February 2017