NCT01738321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 10, 2015

Completed
Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

November 28, 2012

Results QC Date

February 24, 2015

Last Update Submit

February 13, 2017

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Change in Intracuff Pressure

    1 day

Study Arms (2)

Cardiac patients

Patients undergoing cardiac surgery

Other: Cuff pressure

Non-cardiac patients

Patients undergoing any surgery other than cardiac surgery

Other: Cuff pressure

Interventions

Cuff pressureOTHER

Measuring endotracheal tube (ETT) cuff pressure

Cardiac patientsNon-cardiac patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery lasting longer than 4 hours.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4.

    PMID: 25735902DERIVED

Results Point of Contact

Title
Senthil Krishna, MD
Organization
Nationwide Children's Hospital
Senthil.Krishna@nationwidechildrens.org
614-722-4200

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

November 28, 2012

First Posted

November 30, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 21, 2017

Results First Posted

July 10, 2015

Record last verified: 2017-02

Locations

US(1)