Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypercapnic COPD

COPD Clinical Trial

— COPD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928535
• Other study ID #: 261358454
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• High-Flow Nasal Cannula
• Hypercapnia

Intervention

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
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.

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reintubation	The proportion of patients requiring reintubation within 72 hours after extubation	Within 72 hours after extubation
Secondary	RICU length of stay after extubation	Length of time from extubation to discharging from the RICU	From date of extubation until the date of discharging from the RICU up to 28 days
Secondary	Mortality	Mortality after extubation	Within 28 days after extubation
Secondary	Partial pressure of arterial carbon dioxide	Partial pressure of arterial carbon dioxide tested at the appointed time	Within 24 hours before extubation and within 72 hours after extubation