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

NCT03928535 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-26

No results posted yet for this study

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

Interventions

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.

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 Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas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

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928535 on ClinicalTrials.gov