NCT02160522

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

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

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

May 23, 2014

Last Update Submit

June 5, 2015

Conditions

Endotracheal Tube Cuff Pressure Pediatric Emergency

Keywords

Intubationcuffcuffedendotrachealtubepressurepediatricchildchildrenemergency

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cuffed ETT

Patients that are intubated with a cuffed endotracheal tube.

Device: Cuffed ETT

Interventions

Cuffed ETTDEVICE

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

Cuffed ETT

Eligibility Criteria

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

Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.

You may qualify if:

  • cuffed ETT in place on arrival in the ED
  • cuffed ETT placed while in the ED

You may not qualify if:

  • ETT cuff electively left deflated by practitioner
  • Uncuffed ETT used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Ferenczy, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Emergency Medicine Fellow

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 10, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)