Tracheostomy ComplicationNCT04685902
Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
An observational study of Tracheostomy Complication, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- One-way speaking valve
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Laryngectomy
- Uncorrected anatomical anomalies
- Unable to communicate
- Hemodynamically unstable
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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
- Being tested
- One-way speaking valve
- Keywords
- Tracheostomy, Upper airway patency, speaking valve, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-way speaking valveDevice
Also called Passy muir 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.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with tracheostomy | Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial Receives: Device: One-way speaking valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory flow from upper airway
Inspiratory flow from upper airway during one-way speaking valve trial
Measured: 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
Measured: within 1 minute of measuring patient's tidal volume
Tran-tracheal pressure (TTP)
Tran-tracheal pressure (TTP) during one-way speaking valve trial
Measured: within 15 seconds of measuring TTP
leak volume [for mechanically ventilated patients only]
volume leaked from upper airway during invasive ventilation
Measured: 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)
Measured: within 10 minutes of the ultrasound examination
Secondary outcomes (4)
Heart rate during one-way speaking valve trial
Heart rate during one-way speaking valve trial
Measured: 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
Measured: within 15 minutes of placing one-way speaking valve
SpO2 during one-way speaking valve trial
SpO2 during one-way speaking valve trial
Measured: 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
Measured: within 15 minutes of placing one-way speaking valve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study startJun 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Rush University Medical Center
- Investigators
- Jie Li, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685902
- Sponsor's protocol ID
- Trach-PMV-001
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to HIPAA, we would not share the individual participant data
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.
PubMed 24891198Johnson 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.
PubMed 20298366Singh 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.
PubMed 28649385Falcetta 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.
PubMed 29889671
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
- ClinicalTrials.gov ID
- NCT04685902
- Acronym / sponsor ID
- Trach-PMV-001
- Conditions
- Tracheostomy Complication
- Keywords
- Tracheostomy, Upper airway patency, speaking valve, Ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Staffing issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with tracheostomy | – | Device: One-way speaking valveAdult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 18 years and older
- Current RUMC patient
- An order for a one-way speaking valve trial
- Tracheostomy
- PEEP ≤ 10 cm H2O and FIO2 ≤ 50%
Key exclusion criteria (5 listed)
- Laryngectomy
- Uncorrected anatomical anomalies
- Unable to communicate
- Hemodynamically unstable
- Refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-way speaking valveAlso: Passy muir valveOne-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. | Device | Adult patients with tracheostomy |
Primary outcome
Inspiratory flow from upper airway
Time frame: within 1 minute of measuring patient's inspiratory flow
Inspiratory flow from upper airway during one-way speaking valve trial
Tidal volume from upper airway
Time frame: within 1 minute of measuring patient's tidal volume
Tidal volume from upper airway during one-way speaking valve trial
Tran-tracheal pressure (TTP)
Time frame: within 15 seconds of measuring TTP
Tran-tracheal pressure (TTP) during one-way speaking valve trial
leak volume [for mechanically ventilated patients only]
Time frame: within 1 minute of measuring patient's leak volume
volume leaked from upper airway during invasive ventilation
Ultrasound results for upper-airway
Time frame: within 10 minutes of the ultrasound examination
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)
4 secondary outcomes
Heart rate during one-way speaking valve trial
Time frame: within 15 minutes of placing one-way speaking valve
Respiratory rate during one-way speaking valve trial
Time frame: within 15 minutes of placing one-way speaking valve
SpO2 during one-way speaking valve trial
Time frame: within 15 minutes of placing one-way speaking valve
Blood pressure during one-way speaking valve trial
Time frame: within 15 minutes of placing one-way speaking valve
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Results publication: PubMed 24891198Cheung 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.
- Results publication: PubMed 20298366Johnson 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.
- Results publication: PubMed 28649385Singh 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.
- Results publication: PubMed 29889671Falcetta 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.
- Individual participant dataSharing planned: No. Due to HIPAA, we would not share the individual participant data
Related trials for Tracheostomy Complication
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
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Increased Body Temperature Post Tracheostomy: a Retrospective Study
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Outcomes After Tracheal Cannula Removal
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Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
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RecruitingObservational study
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Surveillance, Endoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Li, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheostomy Complication, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory flow from upper airway (time frame: within 1 minute of measuring patient's inspiratory flow). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685902, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.