Verification of Endotracheal Tube Placement by Ultrasound... | NCT01227486

Studies
Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient

NCT01227486

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Nov 24, 2010Estimated

Enrollment

24Estimated

Phase

Not provided

Conditions

Intubation, Intratracheal
Obesity

Interventions

Ultrasound

Countries

Denmark

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

Nov 2010

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

Oct 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 22, 2010

First Posted Date

Oct 25, 2010Estimated

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

Nov 23, 2010

Last Update Posted Date

Nov 24, 2010Estimated

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 determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography.

The investigators hypothesize that ultrasound is a faster method for verifying correct endotracheal tube placement in the obese patient than combined auscultation and capnography.

Detailed Description

Both verification methods are conducted in all patients and patients act as their own control

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese patients for planned surgery and endotracheal intubation			Device: Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound	Device	Ultrasound scan just proximal to the suprasternal notch during intubation and ultrasound scan of both lungs during ventilation	Obese patients for planned surgery and endotracheal intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography		0 to 1 hour

Secondary Outcomes

Measure	Description	Time Frame
Difference in time to correct verification of endotracheal tube placement between ultrasound and auscultation alone		0 to 1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Planned for bariatric surgery in general anaesthesia
Planned for endotracheal intubation
BMI above 30

Exclusion Criteria:

Predicted difficult airway in the pre-anaesthesia airway evaluation.
Unpredicted difficult airway during induction of anaesthesia where assistance is needed by the investigators.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Obese patients admitted for planned bariatric surgery on Glostrup Hospital, Denmark

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Isbye, M.D., PhD.	Department of Anaesthesiology, Copenhagen University Hospital Bispbjerg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology, Bariatric section. Copenhagen University Hospital Glostrup		Glostrup Municipality		DK-2600	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided