NHF vs NIV in Patients With Acute Exacerbation of COPD

February 18, 2020 updated by: ISCHAKI ELENI, Evangelismos Hospital

Nasal High Flow Versus Non-Invasive Ventilation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD exacerbation, a great percentage of patients (~30%) present contraindications to NIV or cannot tolerate it. Nasal high flow (NHF) has been introduced for the management of hypoxemic respiratory failure in adults with favorable effects on ventilation and respiratory mechanics. The above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of non-invasive ventilation (NIV) in COPD exacerbation has increased significantly over time since it has been shown to improve acute respiratory acidosis (increases pH and decreases PaCO2), decrease respiratory rate, work of breathing, severity of breathlessness and therefore reduce mortality and intubation rates.

Despite all these favorable effect, a great percentage of patients (~30%) present contraindications to NIV or cannot tolerate it increasing thus the possibility of NIV failure and consequently intubation rates.

Over the past decade, nasal high flow (NHF) oxygen therapy has been introduced for the management of hypoxemic respiratory failure in adults. NHF can generate high flow rates up to 60 L·min-1 and through this mechanism exerts its positive effects on respiratory mechanics, carbon dioxide washout, patient's respiratory rate and work of breathing. Although the above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia, NHF use in COPD exacerbation is questionable and only a few case reports studies have been published showing favorable effects of NHF on COPD exacerbation.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Study Type

Interventional

Enrollment (Anticipated)

498

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 10673
        • Recruiting
        • Evangelismos Hospital
        • Contact:
      • Larisa, Greece, 41110
    • Crete
      • Heraklion, Crete, Greece, 71409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy

    • 7,25<pH<7,35
    • PaCO2>45mmHg
    • RR>23
  • Ability to obtain written informed consent by the patient or patient's next of kin

Exclusion Criteria:

  • severe facial deformity
  • Facial burns
  • Fixed upper airway obstruction

  • Criteria for imminent intubation and invasive mechanical ventilation (any of the following)

    • respiratory or cardiac arrest
    • gasping respiration
    • pH <7.15
    • depressed consciousness (Glasgow Coma Score <8)
    • psychomotor agitation inadequately controlled by sedation
    • massive aspiration
    • persistent inability to remove respiratory secretions
    • heart rate < 50 ·min-1 with loss of alertness
    • severe hemodynamic instability without response to fluids and vasoactive drugs
    • severe ventricular arrhythmias

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasal High Flow
Patients randomized to NHF device with initial settings of flow=50-60 L·min-1, temperature=37ο Celsius and FiO2 adjusted to maintain SpO2 between 88%-92%.
Device: Nasal High Flow
Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NHF it will be commence immediately with pre-defined settings
Active Comparator: Non-Invasive Ventilation
Patients randomized to NIV with initial settings EPAP=3cmH2O, IPAP=15cmH2O, I:E=1:2 to 1:3, inspiratory time=0.8-1.2sec and FiO2 adjusted to maintain SpO2 between 88%-92%.
Device: Non-Invasive Ventilation
Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NIV it will be commence immediately with pre-defined settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of treatment failure
Time Frame: The first assessment will be held at 2 hours
As treatment failure is defined any need to switch to other treatment group because of discomfort, intolerance or failure to improve physiologic parameters (especially respiratory rate and ABG) despite optimum settings
The first assessment will be held at 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on respiratory rate
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
This secondary outcome includes changes on respiratory rate (breaths per minute)
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Changes on arterial partial pressure of oxygen
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
This secondary outcome includes changes on arterial partial pressure of oxygen values (unit of measure will be mmHg)
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Changes on arterial partial pressure of carbon dioxide
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
This secondary outcome includes changes on arterial partial pressure of carbon dioxide (unit of measure will be mmHg)
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Changes on arterial pH
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
This secondary outcome includes changes on arterial pH values
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Changes on respiratory accessory muscle use
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
This secondary outcome includes recording of respiratory accessory muscle use (recording will be yes or no)
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Patient's dyspnea
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3 (in those subjects whose neurological status allowed them to complete the evaluation)
Dyspnea will be assessed with a 10-point visual analog scale and also Borg scale for dyspnea
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3 (in those subjects whose neurological status allowed them to complete the evaluation)
Pulmonary complications
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Any pulmonary complication will be assessed and correlated with the allocated treatment
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3.
Extrapulmonary complications
Time Frame: They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3
Any extrapulmonary complication will be assessed and correlated with the allocated treatment
They will be assessed on baseline, before NIV or NHF initiation, and on 1, 2, 4, 6, 12, 24, 48 hours and once daily after day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelismos Hospital

Collaborators

Larissa University Hospital
Sotiria General Hospital
Venizeleio General Hospital, Heraklion, Crete

Investigators

  • Principal Investigator: Spyros Zakynthinos, MD, PhD, FCCP, Evangelismos Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48/28-02-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Information that are planned to be shared re study protocol, statistical analysis and clinical study report. They will be shared after 3 months of study publication to anyone who is interested in writing a meta-analysis or review

IPD Sharing Time Frame

3 months after publication

IPD Sharing Access Criteria

To anyone who is interested in writing a meta-analysis or review

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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