A randomized control trial comparing high flow oxygen therapy with low level pressure support during spontaneous breathing trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190703002

Enrollment

162

Registered

2019-07-03

Start date

2019-09-16

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

None listed

Interventions

Participant will receive SBT with high flow oxygen therapy via mask (flow rate 50 LPM,FiO2 0.4 and temperature 37oc) for 30 minutes.,Participant wil receive SBT with low level pressure support (PS 8 c

Experimental Device,Active Comparator Device

high-flow oxygen mask,low level pressure support

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-90 years 2. On mechanical ventilation for at least 24 hours 3. Ready to wean by the following criteria - FiO2 < 0.5 - Positive end expiratory pressure < 8 cmH2O - PaO2/FiO2 > 200 mmHg or SpO2 > 92% - Respiratory rate < 30/min - Stable hemodynamic (without or receiving norepinephrine less than 0.05 mcg/kg/min) - Well cooperate 4. Agree to participate

Exclusion criteria

Exclusion criteria: 1. Unstable hemodynamics: at least one of the following criteria - SBP > 180 or < 90 mmHg - DBP > 120 or < 60 mmHg - Heart rate > 140 or < 60/min - Presence of shock or poor tissue perfusion 2. Severe acid-base disturbance: pH < 7.3 or > 7.55 3. Pregnant women 4. Trachostomized patients

Design outcomes

Primary

Measure	Time frame
Rate of SBT success 30 minutes SBT	—

Secondary

Measure	Time frame
Extubation within 48 hours of SBT success 48 hours extubation,Blood pressure 30 minutes non-invasive blood pressure measurement,Heart rate 30 minutes heart rate,Oxygen saturation 30 minutes pulse oximetry,Reintubation within 48 hours after extubation 48 hours reintubation,Hospital mortality at discharge mortality	—

Countries

Thailand

Contacts

Public ContactDr. Nuttapol Rittayamai

Faculty of Medicine Siriraj Hospital, Mahidol University

nuttapol.rit@mahidol.ac.th024197757

Outcome results