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

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.

Study Overview

• Status: Withdrawn
• Conditions: Tracheostomy Complication
• Intervention / Treatment: Device: One-way speaking valve

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with tracheostomy; Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial	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.; Other Names: Passy muir valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Tran-tracheal pressure (TTP)	Tran-tracheal pressure (TTP) during one-way speaking valve trial	within 15 seconds of measuring TTP
leak volume [for mechanically ventilated patients only]	volume leaked from upper airway during invasive ventilation	within 1 minute of measuring patient's leak volume
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
SpO2 during one-way speaking valve trial	SpO2 during one-way speaking valve trial	within 15 minutes of placing one-way speaking valve
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

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Tracheostomy; speaking valve; Upper airway patency
• Other Study ID Numbers: Trach-PMV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to HIPAA, we would not share the individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No