An interventional study of HFNO and NIV in Acute Exacerbation of COPD, sponsored by Franciscus Gasthuis. Recruiting at 4 sites in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Franciscus Gasthuis · Not applicable, Interventional, and Other
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
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Franciscus Gasthuis is the lead sponsor of 18 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Respiratory support with HFNO (as opposed to NIV, as per standard of care)
Respiratory support with Non-invasive ventilation, standard of care
feasilibity to perform a larger RCT inclusion rate
Inclusion rate
Time frame: 1 year
feasibility to perform a larger RCT screening rate
Screening rate
Time frame: 1 year
feasibility to perform a larger RCTperceived
perceived feasibility as qualified by staff and nurses
Time frame: 1 year
feasibility to perform a larger RCT protocol deviations
protocol deviations
Time frame: 1 year
Treatment failure
cross-over, invasive mechanical ventilation, death
Time frame: 30 days
duration of intervention
time of respiratory support
Time frame: 30 days
need for sedation
use of sedatives, and type of sedation
Time frame: untill end of ICU admission
heart rate
beats per minute
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
respiratory rate
breaths per minute
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood pressure
systolic and diastolic pressure in mmHg
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
SpO2
peripheral saturation by pulsoxymeter (in %)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood gas
with pH, PO2, PCO2, bicarbonate
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
dyspnea score
Borg dyspnea score (0-10 on VAS)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Clinical Parameters
heart rate, respiratory rate, blood pressure, Spo2, arterial blood gas, dyspnea score, glasgow coma scale, RASS, seceretions
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
consciousness
glasgow coma scale (EMV)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
agitation and sedation level
Richmond Agitation and Sedation scale (RASS)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
secretions
(as 0 (absent), 1 (low quantity), 2 (intermediate), 3 (abundant), or 4 (very abundant) little to normal/abundant)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters flow
flow in L/min
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters FiO2
FiO2 in %
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters temperature
temperature in Celcius
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PEEP
PEEP in cmH2O
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PS
PS in cmH2O
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters: FiO2
FiO2 in %
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
(dys)comfort score
10 point VAS scale
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HACOR score
calculated from abovementioned parameters (pH, conciousness, PaO2/Fio2, respiratory rate)
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
facial pressure sores
scored daily: yes or no, and if yes: grade 1-4
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
nursing effort
respiratory support interventions per 2 hour by peat list
Time frame: first 6 hours of study
nursing effort VAS
experienced nursing effort at a VAS scale from 1-10
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
30d mortality
mortality
Time frame: 30 days
90d mortality
mortality
Time frame: 90 days
90d quality of life EQ5D
EQ5D
Time frame: 90 days
90d quality of life SF36
SF-36
Time frame: 90 days
90d anxiety and depression
HADS
Time frame: 90 days
90d PTDS
IES-R
Time frame: 90 days
90d PTSD
IES-R
Time frame: 90 days
90d dyspnea CCQ
CCQ
Time frame: 90 days
90d dyspnea MRC
MRC
Time frame: 90 days
need for intubation and mechanical ventilation
intubation
Time frame: during ICU admission
need for switch to other modality
cross over to NIV from HFNO or from HFNO to NIV
Time frame: during ICU admission
reason of treatment failure
reason of treatment failure: clinical deterioration, failure to improve, other.
Time frame: during ICU admission
expression of treatment failure
worsening of pH, PaCO2, respiratory rate, consiousness, agitation/discomfort, other
Time frame: during ICU admission
Plan to share: No
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