Not Yet RecruitingNot Applicable

The Effect of Speaking Valve on Physiological Parameters With Wearable Devices

China120 participantsStarted 2026-01-31

Plain-language summary

To explore the effect of speaking valves on physiological parameters of tracheostomized patients with wearable devices.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is not receiving mechanical ventilation.
. Tolerates cuff deflation.
. Upper airway patency is good, TTP \< 10 cmH2O.
. Hemodynamically stable, no organ failure, and no sepsis, Pulmonary infection is controlled.
. PaCO2\<60 mmHg.

Exclusion criteria

. Cannot tolerate deflation balloon.
. Severe upper airway obstruction
. Unstable vital signs.
. Thick secretions, compromised airway protection.
. PaCO2 ≥60 mmHg.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of differences in key physiological parameters between two patient groups

Timeframe: Specified assessment window:From 1 hour before initiation of speaking valve use to 1 hour after speaking valve removal (wearable devices monitoring period).

Trial details

NCT IDNCT07422350

SponsorJingyi Ge

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-20

Contact for this trial

Bin Zhang

+8618600530758 zbzgzjz@sina.com

View on ClinicalTrials.gov More Tracheostomy Decannulation trials