Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD (COPD)
|ClinicalTrials.gov Identifier: NCT03928535|
Recruitment Status : Active, not recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|High-Flow Nasal Cannula COPD||Device: High-FlowNasal Cannula Device: Noninvasive Ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD，a Randomized Controlled Trial|
|Actual Study Start Date :||May 1, 2016|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
High-Flow Nasal Cannula
High-flow oxygen was applied immediately after extubation through specific nasal cannula.
Device: High-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.
Noninvasive Ventilation was applied immediately after extubation.
Device: Noninvasive 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 Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas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.
- Rate of reintubation [ Time Frame: Within 72 hours after extubation ]The proportion of patients requiring reintubation within 72 hours after extubation
- RICU length of stay after extubation [ Time Frame: 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 [ Time Frame: Within 28 days after extubation ]Mortality after extubation
- Partial pressure of arterial carbon dioxide [ Time Frame: Within 24 hours before extubation and within 72 hours after extubation ]Partial pressure of arterial carbon dioxide tested at the appointed time
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928535
|Changsha, Hunan, China, 410008|