NCT07183670

Brief Summary

To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) in rehabilitation hospitals.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026May 2027

First Submitted

Initial submission to the registry

September 4, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

September 4, 2025

Last Update Submit

July 30, 2026

Conditions

Prolonged Disorders of ConsciousnessTracheostomy

Keywords

DecannulationProtocolRehabilitationProlonged disorders of consciousnessSpeaking wave

Outcome Measures

Primary Outcomes (1)

  • Decannulation success rate

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

    At 48 hours post decannulation

Secondary Outcomes (4)

  • Coma Recovery Scale-Revised (CRS-R) scores

    through study completion, an average of 1 year

  • CRS-R change rate

    At a week post decannulation

  • Time to decannulation

    through study completion, an average of 1 year

  • Reintubation rate

    90days follow-up

Study Arms (2)

Decannulation Cohort

Patients who pass decannulation protocol

Diagnostic Test: decannulation protocol

Not-decannulation Cohort

Patients failing at any protocol stage

Diagnostic Test: decannulation protocol

Interventions

decannulation protocolDIAGNOSTIC_TEST

Step 1: The patient's clinical stability is confirmed. Step 2: Tolerance to the speaking valve is assessed. Step 3: The wearing time of the speaking valve is extended continuously for 4 h, and no tracheostomy cannula is used for sputum suction within 4 h. Step 4: Cough strength is evaluated to be good before decannulation. Decannulation Criteria: Pass Step 1 + Step 2 + Step 3 + Step 4

Decannulation CohortNot-decannulation Cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Condition: Prolonged Disorders of Consciousness (DOC \>28 days) Population: Tracheostomized adults in hospitals

You may qualify if:

  • Tracheostomy status
  • The duration of consciousness disorders\> 28 days
  • CRS-R score \>0 and \<17
  • Signed informed consent by legal representative

You may not qualify if:

  • Non-PDOC tracheostomy patients
  • Death within 2 weeks post-referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

Location

Beijing Rehabilitation Hospital, Capital Medical University

Beijing, China

Location

Related Publications (3)

  • Hakiki B, Draghi F, Pancani S, Portaccio E, Grippo A, Binazzi B, Tofani A, Scarpino M, Macchi C, Cecchi F. Decannulation After a Severe Acquired Brain Injury. Arch Phys Med Rehabil. 2020 Nov;101(11):1906-1913. doi: 10.1016/j.apmr.2020.05.004. Epub 2020 May 16.

    PMID: 32428445BACKGROUND

  • Draghi F, Pancani S, De Nisco A, Romoli AM, Maccanti D, Burali R, Grippo A, Macchi C, Cecchi F, Hakiki B. Implications of the Consciousness State on Decannulation in Patients With a Prolonged Disorder of Consciousness. Arch Phys Med Rehabil. 2024 Sep;105(9):1691-1699. doi: 10.1016/j.apmr.2024.05.006. Epub 2024 May 10.

    PMID: 38734048BACKGROUND

  • Zhou T, Wang J, Zhang C, Zhang B, Guo H, Yang B, Li Q, Ge J, Li Y, Niu G, Gao H, Jiang H. Tracheostomy decannulation protocol in patients with prolonged tracheostomy referred to a rehabilitation hospital: a prospective cohort study. J Intensive Care. 2022 Jul 16;10(1):34. doi: 10.1186/s40560-022-00626-3.

    PMID: 35842715BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples without DNA

Study Officials

  • Hongying Jiang

    Beijing Rehabilitation Hospital, Capital Medical University, Beijing

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 19, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)