Cuff Pressure in Patients: Manometer vs Invasive Pressure... | NCT01885793

Studies
Cuff Pressure in Patients: Manometer vs Invasive Pressure Monitoring Setup

NCT01885793

Sponsor

Senthil G. Krishna

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Anesthesia Intubation Complication

Interventions

Cuffed endotracheal tube

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

Jan 2017

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

Apr 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 18, 2013

First Submission Date that Met QC Criteria

Jun 24, 2013

First Posted Date

Jun 25, 2013Estimated

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

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Senthil G. Krishna, Assistant Clinical Professor, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Senthil G. KrishnaOTHER

Collaborators

Not provided

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

This is a prospective study looking at ways to measure the cuff pressure of cuffed endotracheal tubes (ETTs). We will be comparing a hand-held manometer (MM) to the transducer of an invasive pressure monitoring setup (IPMS), which is commonly used for arterial or central venous pressure monitoring. The investigators previously did this study in vivo with ETTs in polyvinyl chloride (PVC) "tracheas" and we found that there is good correlation between the pressure readings using the MM and the IPMS. The purpose of the current study is to validate the in vitro findings in clinical situations.

Detailed Description

Not provided

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

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cuffed endotracheal tube		Surgical patients who require endotracheal intubation with a cuffed endotracheal tube (ETT).	Device: Cuffed endotracheal tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cuffed endotracheal tube	Device	Intubation with a cuffed endotracheal tube (ETT).	Cuffed endotracheal tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracuff pressure	Intracuff pressure is measured via handheld manometer and by using the transducer of an invasive pressure monitoring device.	Immediately after intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intubation of trachea with a cuffed endotracheal tube.

Exclusion Criteria:

None

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

Surgical patients that require endotracheal intubation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Senthil Gopalakrishnan, MD	Nationwide Children's Hospital	Principal Investigator

Locations

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