NCT01649882

Brief Summary

Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To date, no test that can verify this right after intubation at the bedside exists. Indirect tests have false negative and positive results leading to complications or at least difficulties in performing effective ventilation of patients. Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or useful in routine intubations, it may prove useful in difficult or questionable cases, where current clinical exams/techniques may not offer a reliable indication of endotracheal tube depth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

3.4 years

First QC Date

July 20, 2012

Last Update Submit

May 29, 2015

Conditions

Keywords

endotracheal tube positionintubation

Outcome Measures

Primary Outcomes (1)

  • concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ

    15 minutes

Secondary Outcomes (1)

  • distance between endotracheal tube cuff and aortic arch by ultrasound in situ

    15 minutes

Study Arms (1)

US ETT (ultrasound endotracheal tube)

EXPERIMENTAL

Subjects will have a brief (\< 15 minutes) ultrasound exam of the neck after intubation. The cuff of the endotracheal tube as well as the aortic arch will be identified. The distance between the two structures will be measured and recorded.

Procedure: US ETT (ultrasound endotracheal tube)

Interventions

Subjects will have a brief (\< 15 minutes) ultrasound exam of the neck after intubation. The cuff of the endotracheal tube as well as the aortic arch will be identified. The distance between the two structures will be measured and recorded.

Also known as: Ultrasound exam
US ETT (ultrasound endotracheal tube)

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • requiring anesthesia with an endotracheal tube placed for surgical or procedural purposes
  • elective or stable and awake for urgent or emergent surgeries

You may not qualify if:

  • known tracheal deformities
  • thoracic aortic aneurysm
  • neck/chest tissue thickness making U/S scanning difficult
  • severe trauma, head injuries or any procedures that require immediate surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

RECRUITING

Study Officials

  • Kai Schoenhage, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Anesthesiology Director of Perioperative Services, Director of Liver Transplant Anesthesia, Department of Anesthesiology

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations