Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD (COPD)
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|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 Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928535
|Changsha, Hunan, China, 410008|