Endotracheal Tube (ETT) Cuff Pressure Study in the Emerge... | NCT02160522

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

NCT02160522

Sponsor

Edward Ferenczy

Status

Completed

Last Update Posted

Jun 8, 2015Estimated

Enrollment

104Actual

Phase

Not provided

Conditions

Endotracheal Tube Cuff Pressure Pediatric Emergency

Interventions

Cuffed ETT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

May 23, 2014

First Submission Date that Met QC Criteria

Jun 7, 2014

First Posted Date

Jun 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2015

Last Update Posted Date

Jun 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cuffed ETT		Patients that are intubated with a cuffed endotracheal tube.	Device: Cuffed ETT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cuffed ETT	Device	Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.	Cuffed ETT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward Ferenczy, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

Not provided