Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial

Rush

Status

Withdrawn

Conditions

Tracheostomy Complication

Treatments

Device: One-way speaking valve

Study type

Observational

Funder types

Other

Identifiers

NCT04685902

Trach-PMV-001

Details and patient eligibility

About

Approximately 24% of ICU patients require the use of a tracheostomy, which impacts vocalization. A one-way speaking valve (SV) can be used to restore vocalization for this patient population. However, if a patient has an obstructed upper airway, SV placement has potential to pose a risk as it might cause asphyxia or even cardiac arrest within minutes, due to the sudden increased intra-thoracic pressure and decreased venous return. Therefore, upper airway patency is crucial in the patient's tolerability and safety to use SV. However, little is available to assess patient's upper airway patency before SV placement. Currently, the predominate way to evaluate readiness is the clinician's subjective assessment based on the quality of vocalization, perceived comfort, and tolerance following SV placement. In the previous in vitro study, the upper airway patency was strongly correlated with the trans-tracheal pressure and the inspiratory flow from upper airway during SV trial. Thus this clinical prospective observational study is aimed to validate the two methods with upper airway patency, which will be validated by bedside ultrasound examination as well.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria