The Use of Capnography as a Guide for Oral Intubation | NCT00176683

Studies
The Use of Capnography as a Guide for Oral Intubation

NCT00176683

Sponsor

Rutgers, The State University of New Jersey

Status

Terminated

Last Update Posted

Jan 27, 2017Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Measurement

Interventions

Capnography

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study was suspended because of difficluty maintaining equipment

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Sep 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

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 26, 2017

Last Update Posted Date

Jan 27, 2017Estimated

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

The purpose of this study is to assess if capnography can be utilized to assist in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement.

If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately, this technique will be useful for routine and emergency airway management.

Detailed Description

The purpose of this study is to assess if capnography can be utilized in the process of endotracheal intubation; specifically, in locating the glottic opening. Ultimately this would result in a new use of capnography to aid in securing normal and difficult airways. Currently capnography is only utilized for the confirmation of endotracheal tube placement.

If successful, this study will provide information, and allow for the development of instrumentation that will assist in difficult airway management; specifically, in locating the glottic opening when visualization may be impaired. Ultimately this technique will be useful for routine and emergency airway management.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All comers		capnography used for all consenting subjects	Procedure: Capnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capnography	Procedure	device which measures carbon dioxide at intubation	All comers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
successful intubation		at intubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients for elective surgery, requiring general endotracheal anesthesia

Exclusion Criteria:

Patients with a known or suspected difficult intubation
Patients requiring specialized endotracheal tubes
Patients with a history of tracheostomy
Airway tumor or airway pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients receiving general anesthesia and requiring endotracheal intubation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Glen Atlas, MD, Msc	Rutgers, The State University of New Jersey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Jersey Medical School		Newark	New Jersey	07101	United States