NCT01227486

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

November 24, 2010

Status Verified

November 1, 2010

First QC Date

October 20, 2010

Last Update Submit

November 23, 2010

Conditions

Keywords

Intubation, intratrachealUltrasonographyAuscultationCapnographyObesity

Outcome Measures

Primary Outcomes (1)

  • Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography

    0 to 1 hour

Secondary Outcomes (1)

  • Difference in time to correct verification of endotracheal tube placement between ultrasound and auscultation alone

    0 to 1 hour

Study Arms (1)

Obese patients for planned surgery and endotracheal intubation

Device: Ultrasound

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Bariatric section. Copenhagen University Hospital Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dan Isbye, M.D., PhD.

    Department of Anaesthesiology, Copenhagen University Hospital Bispbjerg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 25, 2010

Study Start

October 1, 2010

Last Updated

November 24, 2010

Record last verified: 2010-11

Locations