NHF vs NIV in Patients With Acute Exacerbation of COPD

Evangelismos Hospital

Status: Unknown

Conditions: Respiratory Failure; Chronic Obstructive Pulmonary Disease; Acute Exacerbation Copd

Treatments: Device: Non-Invasive Ventilation; Device: Nasal High Flow

Study type: Interventional

Funder types: Other

Identifiers

NCT03466385

48/28-02-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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498 participants in 2 patient groups

Nasal High Flow

Experimental group

Description:

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%.

Treatment:

Device: Nasal High Flow

Non-Invasive Ventilation

Active Comparator group

Description:

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%.

Treatment:

Device: Non-Invasive Ventilation