We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01738321
First Posted: November 30, 2012
Last Update Posted: March 21, 2017
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.
Information provided by (Responsible Party):
Senthil G. Krishna, Nationwide Children's Hospital
  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
Surgical Procedure, Unspecified Other: Cuff pressure

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

Further study details as provided by Senthil G. Krishna, 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

  Eligibility

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.


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.
Criteria

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


Locations
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 Submitted: November 28, 2012
First Posted: November 30, 2012
Results First Submitted: February 24, 2015
Results First Posted: July 10, 2015
Last Update Posted: March 21, 2017
Last Verified: February 2017