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

NCT03928535 | Unknown DMC

• 1 other identifier: 261358454
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Flow Nasal Cannula; COPD

Outcome Measures

Primary Outcomes (1)

• Rate of reintubation

  The proportion of patients requiring reintubation within 72 hours after extubation

  Within 72 hours after extubation

Secondary Outcomes (3)

• RICU length of stay after extubation

  From date of extubation until the date of discharging from the RICU up to 28 days

• Mortality

  Within 28 days after extubation

• Partial pressure of arterial carbon dioxide

  Within 24 hours before extubation and within 72 hours after extubation

Study Arms (2)

High-Flow Nasal Cannula

OTHER

High-flow oxygen was applied immediately after extubation through specific nasal cannula.

Device: High-FlowNasal Cannula

Noninvasive Ventilation

OTHER

Noninvasive Ventilation was applied immediately after extubation.

Device: Noninvasive Ventilation

Interventions

High-FlowNasal Cannula DEVICE

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.

High-Flow Nasal Cannula

Noninvasive Ventilation DEVICE

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 Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas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.

Noninvasive Ventilation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do-not-intubate
• Tracheostomies
• Accidental extubation
• Self-extubation

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 26, 2019
• Study Start: May 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 26, 2019

Record last verified: 2018-12

Locations

CN (1)