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 range18 Years – 90 Years

SexALL

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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.

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