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

Tracheostomy Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04685902
• Other study ID #: Trach-PMV-001
• Status: Withdrawn
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy Complication

Intervention

Device:
• One-way speaking valve
One-way speaking valve is a small device that attaches to the tracheostomy tube, to allows tracheostomy patient to breathe in through his or her trach tube. After the inhalation, the speaking valve closes. Air is breathed out (exhaled) up through the vocal cords, then through the mouth and nose.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View 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 — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory flow from upper airway	Inspiratory flow from upper airway during one-way speaking valve trial	within 1 minute of measuring patient's inspiratory flow
Primary	Tidal volume from upper airway	Tidal volume from upper airway during one-way speaking valve trial	within 1 minute of measuring patient's tidal volume
Primary	Tran-tracheal pressure (TTP)	Tran-tracheal pressure (TTP) during one-way speaking valve trial	within 15 seconds of measuring TTP
Primary	leak volume [for mechanically ventilated patients only]	volume leaked from upper airway during invasive ventilation	within 1 minute of measuring patient's leak volume
Primary	Ultrasound results for upper-airway	Ultrasound results include pre-epiglottic space distance/epiglottitis to middle distance of vocal cords (Pre-E/E-VC), thyrohyoid membrane (DSEM), and hyomental distance ratio (HMDR)	within 10 minutes of the ultrasound examination
Secondary	Heart rate during one-way speaking valve trial	Heart rate during one-way speaking valve trial	within 15 minutes of placing one-way speaking valve
Secondary	Respiratory rate during one-way speaking valve trial	Respiratory rate during one-way speaking valve trial	within 15 minutes of placing one-way speaking valve
Secondary	SpO2 during one-way speaking valve trial	SpO2 during one-way speaking valve trial	within 15 minutes of placing one-way speaking valve
Secondary	Blood pressure during one-way speaking valve trial	Blood pressure during one-way speaking valve trial	within 15 minutes of placing one-way speaking valve