Recruiting

Observational Study

Sponsor:

Kai Schoenhage

Code:

NCT01649882

Conditions

Intubation, Intratracheal

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

US ETT (ultrasound endotracheal tube)

Study Details

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.

Conditions

Intubation, Intratracheal

Study ID

NCT01649882

Start date

Jul, 2012

Status verified date

May, 2015

Completion date

Jun, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: US ETT (ultrasound endotracheal tube)

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.

Interventions

US ETT (ultrasound endotracheal tube)

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.

Primary outcome measure

  • concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Kai Schoenhage, MD

(520) 626-7221kschoenhage@anesth.arizona.edu

Locations

University of Arizona Medical Center

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Kai Schoenhage, MD

More Information

Sponsor

Kai Schoenhage

Last update posted

Jun 2, 2015

Last verified

May, 2015

Keywords

  • endotracheal tube position
  • intubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kai Schoenhage on 2015-06-02.