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Unassisted breathing through a tracheostomy mask versus standard low-flow cannula oxygen on weaning duration in patients weaning from mechanical ventilation: a single center, randomized, open-label, controlled trial

Unassisted breathing through a tracheostomy mask versus standard low-flow cannula oxygen on weaning duration in patients weaning from mechanical ventilation: a single center, randomized, open-label, controlled trial.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030733
Enrollment
Unknown
Registered
2020-03-12
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-03-16

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

Conditions

Weaning of mechanical ventilation

Interventions

Tracheostomy mask group: Patients randomized to tracheostomy mask were disconnected from the ventilator and were allowed to breathe through the tracheostomy via tracheostomy mask
Cannula oxygen group:Patients randomized to tracheostomy mask were disconnected from the ventilator and were provided with cannula oxygen through the tracheostomy

Sponsors

Critical Care department of Shenzhen Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Consecutive tracheotomized patients aged > 18 years, in ICU settings were screened. Patients will be eligible if they admit to acute respiratory failure and they have not successfully weaned within 24 hours of this first separation attempt after tracheostomy. Within 24 hours of tracheostomy, a separation attempt will be performed when the assessment for weaning is positive. The readiness of weaning is determined by the criteria used in previous studies: (1) reversal of the acute phase of the disease; (2) adequate oxygenation (PaO2 arterial oxygen-PaO2/FiO2 of 150-200 necessitating positive end-expiratory pressure (PEEP) = 8 g/dl).

Exclusion criteria

Exclusion criteria: Patients meet the following criteria excluded for this study: antecedent neuromuscular disease, hemodynamic instability (decompensated heart insufficiency, arrhythmia, acute coronary insufficiency), hemoptysis, spinal cord injury above T8, deep nerve defects, bilateral phrenic nerve injury, need of any type of home mechanical ventilatory support prior to hospitalization, any skeletal pathology that weakens chest wall movements such as severe kyphoscoliosis, congenital anomaly or contractures, poor general prognosis with less than 1 year life expectance.

Design outcomes

Primary

MeasureTime frame
the proportion of successful weaning patients;

Secondary

MeasureTime frame
the patient conditions after 28 days without invasive ventilation;ICU length of stay;hospital length of stay;related adverse events;

Countries

China

Contacts

Public ContactYong Liu

Shenzhen Hospital, Southern Medical University

liuyongjoy@hotmail.com+86 13928415176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026