COPD, High-Flow Nasal Cannula
Conditions
Brief summary
To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.
Interventions
DEVICEHigh-FlowNasal Cannula
High-flowoxygenwas applied immediately after extubation through specific nasal cannula. Flow was initially set at 10 L/min and titrated upwards in 5-L/min steps until patients experienced discomfort.Temperature was initially set to 37°C, unless reported too hot by patients, and FIO2 was regularly adjusted to the target peripheral capillary oxygen saturation (SPO2) of greater than 92%. After 24 hours, high-flow was stopped and, if necessary, patients received conventional oxygen therapy.
DEVICENoninvasive Ventilation
Full face mask NIV was continuously delivered immediately after extubation for a scheduled period of 24 hours after extubation. Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas exchange (arterial oxygen saturation \[SaO2\] 92%, with pH of 7.35). The FIO2 was adjusted to maintain SPO2 at less than 92%. Sedatives to increase tolerance to NIV were not allowed.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of AECOPD * Extubation must be performed after 48 hours of invasive ventilation * Must be treated sequentially with HFNC or NIV after extubation * PaCO2≥50mmHg when extubation * Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation
Exclusion criteria
* Do-not-intubate * Tracheostomies * Accidental extubation * Self-extubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reintubation | Within 72 hours after extubation | The proportion of patients requiring reintubation within 72 hours after extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RICU length of stay after extubation | From date of extubation until the date of discharging from the RICU up to 28 days | Length of time from extubation to discharging from the RICU |
| Mortality | Within 28 days after extubation | Mortality after extubation |
| Partial pressure of arterial carbon dioxide | Within 24 hours before extubation and within 72 hours after extubation | Partial pressure of arterial carbon dioxide tested at the appointed time |
Countries
China
Outcome results
None listed