Novel Device to Assess Endotracheal Tube Migration

NeuroTherapia, Inc.

Status: Completed

Conditions: Mechanically Ventilated Patients Admitted to a MICU

Treatments: Other: AirWave

Study type: Observational

Funder types: Other

Identifiers

NCT01697215

111128-PIP

Details and patient eligibility

About

To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria:

• Oral or nasal endotracheal intubation, anticipated to last at least 48 hours
• Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm
• Subject must be at least 18 years old (no upper age limitation)
• English speaking patients/decision makers.

Exclusion Criteria

• Subjects ventilated through a tracheostomy
• Subjects under 18 years of age

Trial design

42 participants in 1 patient group

Oral or nasal endotracheal intubation

Description:

Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers.

Treatment:

Other: AirWave