Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Senthil Gopalakrishnan, Nationwide Children's Hospital
First received: November 28, 2012
Last updated: January 29, 2014
Last verified: January 2014
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.
Surgeries Greater Than 4 Hours.
Other: Cuff pressure
||Observational Model: Cohort
Time Perspective: Prospective
Primary Outcome Measures:
- Cuff pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Other: Cuff pressure
Measuring endotracheal tube (ETT) cuff pressure
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing surgery lasting longer than 4 hours.
- Patients in whom a cuffed endotracheal tube is to be used for surgical procedures of more than 4 hours.
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
|Nationwide Children's Hospital
|Columbus, Ohio, United States, 43205 |
No publications provided
ClinicalTrials.gov processed this record on October 01, 2014
||Senthil Gopalakrishnan, Assistant Clinical Professor, Nationwide Children's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 28, 2012
||January 29, 2014
||United States: Institutional Review Board