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

NCT04685902 | Withdrawn

• 1 other identifier: Trach-PMV-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication

Keywords

Tracheostomy; Upper airway patency; speaking valve; Ultrasound

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

  within 15 minutes of placing one-way speaking valve

• SpO2 during one-way speaking valve trial

  within 15 minutes of placing one-way speaking valve

• Blood pressure during one-way speaking valve trial

  within 15 minutes of placing one-way speaking valve

Study Arms (1)

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

Interventions

One-way speaking valve DEVICE

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.

Also known as: Passy muir valve

Adult patients with tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related 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.

  PMID: 24891198 RESULT

• 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.

  PMID: 20298366 RESULT

• 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.

  PMID: 28649385 RESULT

• 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.

  PMID: 29889671 RESULT

Study Officials

• Jie Li, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)