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Early decannulation based on suction frequency in tracheostomized individuals with brainstem damage: a multicenter randomized controlled trial

Early decannulation based on suction frequency in tracheostomized individuals with brainstem damage: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126509
Enrollment
Unknown
Registered
2026-06-10
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shortness of breath

Interventions

Experimental group:Extubation criteria: Suction frequency = 2 times/8h within 24 hours
extubate directly once the criteria are met.
Control group:Extubation criteria: When the frequency of suctioning is =1 time/4 hours within 12 hours, a progressive (based on patient tolerance, from half-blocking to full-blocking) capping trial is
once the extubation criteria are met, extubation is performed directly.

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-79 years old; 2. Normal body temperature, hemodynamically stable; tracheostomy in place, no need for mechanical ventilation; 3. Brainstem injury caused by cerebral infarction, cerebral hemorrhage, traumatic brain injury, etc., within the past 3 months; 4. At least one of the following three criteria is met:; Consciousness disorder other than deep coma; Severe swallowing disorder: water swallow test grade >= 3, with obvious or covert aspiration; Vocal cord abduction disorder; 5. The patient's authorized representative signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Fiberoptic laryngoscopy shows that after deflation of the tracheostomy tube cuff and with the tube occluded, the maximum width of the glottic fissure is less than one-third of its length, or the duration of abduction is less than 1 second; 2.Fiberoptic laryngoscopy shows >50% stenosis of the tracheal lumen in the main trachea between the glottis and the tracheostomy stoma.

Design outcomes

Primary

MeasureTime frame
Time from admission to actual decannulation;

Secondary

MeasureTime frame
Functional Oral Intake,FOIS;Decannulation failure;Worsening of pulmonary infection;Peak expiratory flow rate;2-week decannulation rate;

Countries

China

Contacts

Public ContactYuan Ziwen

The First Affiliated Hospital of Xi'an Jiaotong University

yuanziwen@xjtufh.edu.cn+86 29 85324834

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026