Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)

Endotracheal Tube Cuff Pressure Pediatric Emergency Clinical Trial

Official title:

Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160522
• Other study ID #: IRB14-00215
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: June 5, 2015
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

Description:

Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• cuffed ETT in place on arrival in the ED

• cuffed ETT placed while in the ED

Exclusion Criteria:

• ETT cuff electively left deflated by practitioner

• Uncuffed ETT used

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Endotracheal Tube Cuff Pressure Pediatric Emergency

Intervention

Device:
• Cuffed ETT
Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Edward Ferenczy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cuff pressure	One measurement of the ETT cuff pressure after intubation in the emergency department.	One time in the ED prior to discharge to the ICU	No