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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
498

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 81 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Evangelismos Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Larissa University Hospital
Sotiria General Hospital
Venizeleio General Hospital, Heraklion, Crete

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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