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Comparison of Success Rate of Extubation Between SBT with PSV and T-piece in Patients with EFL

Randomized Controlled, Non-inferiority Trial to Comparison of Success Rate of Extubation Between Spontaneous Breathing Trial with PressureSupport Ventilation and T-piece in Patients with Expiratory Flow Limitation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200604003
Enrollment
86
Registered
2020-06-04
Start date
2020-06-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Patients&#44

Interventions

PSV mode : Ps 5 PEEP 5 FiO2 0.3-0.4 to keep SpO2 not less than 90% for 30 minutes,T-piece 10LPM FiO2 0.3-0.4 to keep SpO2 not less than 90% for 30 minutes
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
30-minute SBT with PSV,30-minute SBT wIth T-piece

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older undergoing mechanical ventilation for at least 24 hours 2. Patients who fulfilled the weaning criteria: (all are included) (1) resolution or improvement of the condition leading to intubation (2) hemodynamic stability, defined as systolic blood pressure between 90 and 160 mm Hg and heart rate less than 140/min without vasopressors or with low doses of vasopressors (3) Glasgow Coma Scale score of 13 or greater (4) respiratory stability, defined as oxygen saturation >90% with fraction of inspired oxygen [FiO2] not more than 0.4, respiratory rate <35/min, spontaneous tidal volume >5 mL/kg (5) non copious secretion (not more than 1 aspiration within 2hours)

Exclusion criteria

Exclusion criteria: 1. Patients with tracheostomy 2. Patients with Upper airway obstruction 3. Patients denied to re-intubation

Design outcomes

Primary

MeasureTime frame
Extubation success rate 72 hr after extubation without reintubation Observe and record results by physicians

Secondary

MeasureTime frame
Spontaneous breathing trial success rate 30min after complete Spontaneous breathing trial Observe and record results by physicians,Time to reintubation 7days after extubation Observe and record results by physicians,Reasons for reintubation 7 days after extubation without reintubation Observe and record results by physicians

Countries

Thailand

Contacts

Public ContactYanisa Kluanwan

King Chulalongkorn Memorial Hospital

pupae328@hotmail.com0814804826

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026