Clinical trial NCT04685902: Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
Official title: Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tracheostomy Complication
Keywords: Tracheostomy
Upper airway patency
speaking valve
Ultrasound
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial will be recruited from Rush University Medical Center, Chicago, IL.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Current RUMC patient
* An order for a one-way speaking valve trial
* Tracheostomy
* PEEP ≤ 10 cm H2O and FIO2 ≤ 50%
* English speaking

Exclusion Criteria:

* Laryngectomy
* Uncorrected anatomical anomalies
* Unable to communicate
* Hemodynamically unstable
* Refuse to participate in the study

Primary outcomes:
measure: Inspiratory flow from upper airway
timeFrame: within 1 minute of measuring patient's inspiratory flow
measure: Tidal volume from upper airway
timeFrame: within 1 minute of measuring patient's tidal volume
measure: Tran-tracheal pressure (TTP)
timeFrame: within 15 seconds of measuring TTP
measure: leak volume [for mechanically ventilated patients only]
timeFrame: within 1 minute of measuring patient's leak volume
measure: Ultrasound results for upper-airway
timeFrame: within 10 minutes of the ultrasound examination
Secondary outcomes:
measure: Heart rate during one-way speaking valve trial
timeFrame: within 15 minutes of placing one-way speaking valve
measure: Respiratory rate during one-way speaking valve trial
timeFrame: within 15 minutes of placing one-way speaking valve
measure: SpO2 during one-way speaking valve trial
timeFrame: within 15 minutes of placing one-way speaking valve
measure: Blood pressure during one-way speaking valve trial
timeFrame: within 15 minutes of placing one-way speaking valve
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung NH, Napolitano LM. Tracheostomy: epidemiology, indications, timing, technique, and outcomes. Respir Care. 2014 Jun;59(6):895-915; discussion 916-9. doi: 10.4187/respcare.02971.
citation: Johnson DC, Campbell SL, Rabkin JD. Tracheostomy tube manometry: evaluation of speaking valves, capping and need for downsizing. Clin Respir J. 2009 Jan;3(1):8-14. doi: 10.1111/j.1752-699X.2008.00100.x.
citation: Singh RK, Saran S, Baronia AK. The practice of tracheostomy decannulation-a systematic review. J Intensive Care. 2017 Jun 20;5:38. doi: 10.1186/s40560-017-0234-z. eCollection 2017.
citation: Falcetta S, Cavallo S, Gabbanelli V, Pelaia P, Sorbello M, Zdravkovic I, Donati A. Evaluation of two neck ultrasound measurements as predictors of difficult direct laryngoscopy: A prospective observational study. Eur J Anaesthesiol. 2018 Aug;35(8):605-612. doi: 10.1097/EJA.0000000000000832.