ClinicalTrials.gg
Not yet recruitingNCT07904169SVBDP-TSPUpdated Oct 29, 2026

A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients

An observational study in Stroke Patients and Tracheostomy, sponsored by Hongying Jiang, MD. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Hongying Jiang, MD · Observational

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluate the feasibility of a speaking-valve-based decannulation protocol in tracheostomized stroke patients

Read the detailed description

Some patients with severe stroke require tracheostomy due to prolonged mechanical ventilation or airway protection. Prolonged use of a tracheostomy tube may lead to a range of complications-including infections, tracheal stenosis, and dysphagia or communication difficulties-which can adversely affect patient recovery and quality of life. Therefore, when patients' respiratory function improves and patients acquire the capability for airway protection, timely and safe removal of the tracheostomy tube constitutes a critical step in the rehabilitation process. The research of the investigators' center has demonstrated that a standardized tracheostomy tube removal protocol based on a speaking valve, implemented by the investigators' rehabilitation team, is associated with successful tube removal in patients with long-term tracheostomies. Accordingly, the investigators intend to evaluate the application of this standardized speaking-valve-based tracheostomy tube removal protocol in stroke patients with tracheostomies, aiming to assess its feasibility and safety in this patient population.

02

Conditions studied

  • Stroke Patients
  • Tracheostomy

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03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 207 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Hongying Jiang, MD is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Tracheostomized stroke patients in stable phase of stroke

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Tracheostomy performed following stroke (ischemic or hemorrhagic);
  2. Stable phase of stroke: clinically defined as the intermediate-to-late recovery phase plus the sequelae phase, during which the patient exhibits stable vital signs, resolution of cerebral edema, normalization of intracranial pressure, and absence of new neurological deficits (e.g., no recurrence of hemiplegia or aphasia), thereby entering a phase focused primarily on rehabilitation and secondary prevention.
  3. Written has been obtained and approved by the Institutional Review Board (IRB).

Exclusion criteria

Exclusion Criteria:

  1. Expected survival time \<2 weeks, or planned transfer to another non-cooperative healthcare facility within 2 weeks;
  2. Presence of severe, uncontrolled neurological disorders or other systemic diseases (e.g., advanced cancer, severe heart failure).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (estimated)
Patient registry
No

Groups and cohorts

  • Tracheostomized Stroke Patients

    Tracheostomized Stroke Patients

    Diagnostic Test: Decannulation Protocol

Interventions

  • Diagnostic testDecannulation Protocol

    a Speaking-Valve-Based Decannulation Protocol

06

What researchers measure

Primary outcomes

  1. Decannulation success rate

    (Decannulation - Decannulation failure) / Total number of errolled patients

    Time frame: From the date of enrollment to the date of 48 hours after extubation,assessed up to 9months

Secondary outcomes

  1. Time to decannulation

    Days from clinically stable to decantation

    Time frame: From the date when patients in stable clinical conditions to the date of decannulation,assessed up to 3 months

  2. Reintubation rate

    Unplanned reiteration from 48 hours post decannulation to 90 days follow up

    Time frame: From 48 hours post decannulation to 90 days follow up

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 12 months is below that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 29, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2027
CompletionEst.
Nov 1, 2028
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07904169
Lead sponsor
Hongying Jiang, MD
Collaborators
Beijing Rehabilitation Hospital of Capital Medical University, Beijing Tiantan Hospital, Fengtai Rehabilitation Hospital of Beijing Municipal, Hunan Provincial Rehabilitation Hospital, Anhui Wanbei Rehabilitation Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, The Second People's Hospital of Beihai, Zhengzhou Central Hospital
Responsible party
Hongying Jiang, MD (Principal Investigator, Capital Medical University) — Sponsor-investigator
First posted
Oct 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Qian Feng
Contact
fengqian0263@163.com
010-56981098
Hongying Jiang
Contact
6jhy@163.com
010-56981555
Hongying Jiang
study chair · Beijing Rehabilitation Hospital, Capital Medical University, Beijing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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