Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
270 participants
INTERVENTIONAL
2017-06-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High-Flow Nasal Cannula Oxygenation
High-Flow Nasal Cannula Oxygenation
High-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more.
Noninvasive Positive Pressure Ventilation
Noninvasive Positive Pressure Ventilation
Noninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 \>92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 \>96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg.
Conventional Weaning
Conventional weaning
The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.
Interventions
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High-Flow Nasal Cannula Oxygenation
High-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more.
Noninvasive Positive Pressure Ventilation
Noninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 \>92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 \>96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg.
Conventional weaning
The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.
Eligibility Criteria
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Inclusion Criteria
2. PaO2 \<60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
3. Meeting criteria for weaning readiness；
4. Spontaneous breathing trial failure.
Exclusion Criteria
2. Duration of invasive ventilation \<48h；
3. Tracheotomy；
4. Percentage of cuff leak volume in tidal volume\<15.5%；
5. Unable to spontaneously clear secretions from their airway；
6. Recent oral，nasal，facial or cranial trauma or surgery；
7. Recent gastric or esophageal surgery；
8. Active upper gastro-intestinal bleeding；
9. Severe abdominal distension；
10. Lack of co-operation；
11. Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.
18 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Responsible Party
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Zujin Luo
MD
Locations
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Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BeijingCYH-ICU-005
Identifier Type: -
Identifier Source: org_study_id
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