High Flow Nasal Oxygen for Exacerbation COPD

NCT ID: NCT06084117

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2026-12-01

Brief Summary

In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated

Detailed Description

Rationale: Chronic Obstructive Pulmonary Disease (COPD) is frequently complicated by a worsening of symptoms, known as acute exacerbations (AECOPD). These exacerbations can result in a life-threatening condition with an impaired gas exchange, resulting in hypercapnia and as a result respiratory acidosis. The current standard of care of respiratory support for these patients is non-invasive ventilation (NIV), which has been shown to reduce morbidity and mortality. However, NIV is often unsuccessful, due to intolerance, agitation or patient-ventilation dyssynchrony. Furthermore, NIV is a resource-intensive therapy. High flow nasal oxygen (HFNO) is a non-invasive respiratory support mode that provides heated and humidified gas through soft nasal prongs. Several studies have shown that HFNO improves gas exchange and reduces work of breathing in non-hypercapnic respiratory failure. Furthermore, HFNO is thought to be better tolerated than NIV and the nursing effort may be lower compared to NIV. The hypothesis is that HFNO is non-inferior to NIV for patients with acidotic, hypercapnic AECOPD regarding the need for intubation and mortality, and that it increases patient comfort and reduces nursing effort.

Objective: To assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.

Study design: prospective, randomized, multi-center, unblinded, pilot study. Study population: Patients with acidotic, hypercapnic AECOPD Intervention (if applicable): HFNO versus NIV as first line treatment at presentation Main study parameters/endpoints: Feasibility: screening rate, inclusion rate, feasibility as qualified by staff and nurses.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participating patients will receive standard of care (i.e., admission to the monitored ward or ICU for intensive monitoring and regular blood withdrawals, steroids, bronchodilator inhalation therapy). There will be one extra questionnaire after 3 months, but no extra blood samples or site visits, compared to regular care for the participating patients. Permission of the patient will be obtained to register date of hospital discharge and outcome after ICU discharge and ask them to fill out questionnaires at 3 months after admission about their quality of life. Previous studies have not shown that HFNO is inferior to NIV with regards to outcomes (intubation rate, mortality), albeit that they were not powered to prove non-inferiority.

Conditions

Acute Exacerbation of COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Flow Nasal Oxygen (HFNO)

Patients will start at a flow of 50 L/min and a temperature of 37°C, FiO2¬ will start at 25%, and titrated to target SpO2 (88-92%, as in usual care).

Group Type: EXPERIMENTAL

HFNO

Intervention Type: OTHER

Respiratory support with HFNO (as opposed to NIV, as per standard of care)

Non-Invasive Ventilation (NIV)

Patients will be started at

• Using the facemask interface: EPAP/PEEP set at 5-7 cmH2O and PS of 5-7 cmH2O (equal to IPAP of 10-14 cmH2O).
• Using the helmet interface; EPAP/PEEP set at least 10 cmH2O and PS of 10 cmH2O (equal to IPAP of 20 cmH2O).
• PEEP/EPAP and IPAP/PS can be titrated to effectiveness, tolerance and comfort
• FiO2 should be set to achieve a SpO2 of 88-92%

Group Type: ACTIVE_COMPARATOR

NIV

Intervention Type: OTHER

Respiratory support with Non-invasive ventilation, standard of care

Interventions

HFNO

Respiratory support with HFNO (as opposed to NIV, as per standard of care)

Intervention Type: OTHER

NIV

Respiratory support with Non-invasive ventilation, standard of care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Known chronic obstructive pulmonary disease
• Acute hypercapnic exacerbation of this condition, defined as: PaCO2>45 mmHg or >6.0 kPa and pH 7.20-7.35
• Age >40 years

Exclusion Criteria

• Asthma
• Immediate need for intubation, based on clinical judgement of the attending physician.
• Impossibility to apply either one of the two interventions
• Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).
• Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).
• Impeding death
• Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.
• Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication
• Tracheostomized patients
• Participation in other interventional trials
• Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care / high dependency unit, depending on local infrastructure).
• Previous explicit (or written) objection to participation in research - bicarbonate <20 mmol/L

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reinier de Graaf Groep

OTHER

Sponsor Role: collaborator

Haga Medisch Centrum

UNKNOWN

Sponsor Role: collaborator

Ikazia Hospital, Rotterdam

OTHER

Sponsor Role: collaborator

Franciscus Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorien Kiers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Franciscus Gasthuis & Vlietland

Locations

Reinier de Graaf

Delft, , Netherlands

Site Status: NOT_YET_RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

Site Status: RECRUITING

Ikazia

Rotterdam, , Netherlands

Site Status: NOT_YET_RECRUITING

Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

Dorien Kiers, MD, PhD

Role: CONTACT

d.kiers@franciscus.nl

+3110 461 6161

Facility Contacts

Louise Urlings, MD, PhD

Role: primary

Doiren Kiers, MD, PhD

Role: primary

Susanne Stads, MD, PhD

Role: primary

Peter van Vliet, MD, PhD

Role: primary

Other Identifiers

HiCAP

Identifier Type: -

Identifier Source: org_study_id