NCT06084117

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2024Dec 2026

First Submitted

Initial submission to the registry

October 2, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 14, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

October 2, 2023

Last Update Submit

August 20, 2025

Conditions

Acute Exacerbation of COPD

Outcome Measures

Primary Outcomes (4)

  • feasilibity to perform a larger RCT inclusion rate

    Inclusion rate

    1 year

  • feasibility to perform a larger RCT screening rate

    Screening rate

    1 year

  • feasibility to perform a larger RCTperceived

    perceived feasibility as qualified by staff and nurses

    1 year

  • feasibility to perform a larger RCT protocol deviations

    protocol deviations

    1 year

Secondary Outcomes (37)

  • Treatment failure

    30 days

  • duration of intervention

    30 days

  • need for sedation

    untill end of ICU admission

  • heart rate

    at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge

  • respiratory rate

    at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge

  • +32 more secondary outcomes

Study Arms (2)

High Flow Nasal Oxygen (HFNO)

EXPERIMENTAL

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).

Other: HFNO

Non-Invasive Ventilation (NIV)

ACTIVE COMPARATOR

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%

Other: NIV

Interventions

HFNOOTHER

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

High Flow Nasal Oxygen (HFNO)
NIVOTHER

Respiratory support with Non-invasive ventilation, standard of care

Non-Invasive Ventilation (NIV)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Reinier de Graaf

Delft, Netherlands

NOT YET RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, Netherlands

RECRUITING

Ikazia

Rotterdam, Netherlands

NOT YET RECRUITING

Haaglanden Medisch Centrum

The Hague, Netherlands

NOT YET RECRUITING

Study Officials

  • Dorien Kiers, MD, PhD

    Franciscus Gasthuis & Vlietland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorien Kiers, MD, PhD

CONTACT

+3110 461 6161d.kiers@franciscus.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: pilot randomized unblinded controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 16, 2023

Study Start

May 14, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)