Acute Exacerbation of COPDHiCAPNCT06084117
High Flow Nasal Oxygen for Exacerbation COPD
A study testing HFNO and NIV in people with Acute Exacerbation of COPD, run by Franciscus Gasthuis at 4 sites in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- HFNO and NIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesNetherlands
- Study dates
- 14 May 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Not yet recruiting
Reinier de Graaf
Delft
Louise Urlings, MD, PhD
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam
Doiren Kiers, MD, PhD
- Not yet recruiting
Ikazia
Rotterdam
Susanne Stads, MD, PhD
- Not yet recruiting
Haaglanden Medisch Centrum
The Hague
Peter van Vliet, MD, PhD
About this study
Official title: High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
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
Read the 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
- Being tested
- HFNO, NIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNOOther
Respiratory support with HFNO (as opposed to NIV, as per standard of care)
NIVOther
Respiratory support with Non-invasive ventilation, standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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% Receives: Other: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasilibity to perform a larger RCT inclusion rate
Inclusion rate
Measured: 1 year
feasibility to perform a larger RCT screening rate
Screening rate
Measured: 1 year
feasibility to perform a larger RCTperceived
perceived feasibility as qualified by staff and nurses
Measured: 1 year
feasibility to perform a larger RCT protocol deviations
protocol deviations
Measured: 1 year
Secondary outcomes (37)
Treatment failure
cross-over, invasive mechanical ventilation, death
Measured: 30 days
duration of intervention
time of respiratory support
Measured: 30 days
need for sedation
use of sedatives, and type of sedation
Measured: untill end of ICU admission
heart rate
beats per minute
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
respiratory rate
breaths per minute
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood pressure
systolic and diastolic pressure in mmHg
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
SpO2
peripheral saturation by pulsoxymeter (in %)
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood gas
with pH, PO2, PCO2, bicarbonate
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
dyspnea score
Borg dyspnea score (0-10 on VAS)
Measured: 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
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
consciousness
glasgow coma scale (EMV)
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
agitation and sedation level
Richmond Agitation and Sedation scale (RASS)
Measured: 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)
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters flow
flow in L/min
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters FiO2
FiO2 in %
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters temperature
temperature in Celcius
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PEEP
PEEP in cmH2O
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PS
PS in cmH2O
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters: FiO2
FiO2 in %
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
(dys)comfort score
10 point VAS scale
Measured: 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)
Measured: 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
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
nursing effort
respiratory support interventions per 2 hour by peat list
Measured: first 6 hours of study
nursing effort VAS
experienced nursing effort at a VAS scale from 1-10
Measured: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
30d mortality
mortality
Measured: 30 days
90d mortality
mortality
Measured: 90 days
90d quality of life EQ5D
EQ5D
Measured: 90 days
90d quality of life SF36
SF-36
Measured: 90 days
90d anxiety and depression
HADS
Measured: 90 days
90d PTDS
IES-R
Measured: 90 days
90d PTSD
IES-R
Measured: 90 days
90d dyspnea CCQ
CCQ
Measured: 90 days
90d dyspnea MRC
MRC
Measured: 90 days
need for intubation and mechanical ventilation
intubation
Measured: during ICU admission
need for switch to other modality
cross over to NIV from HFNO or from HFNO to NIV
Measured: during ICU admission
reason of treatment failure
reason of treatment failure: clinical deterioration, failure to improve, other.
Measured: during ICU admission
expression of treatment failure
worsening of pH, PaCO2, respiratory rate, consiousness, agitation/discomfort, other
Measured: during ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start14 May 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized unblinded controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Haga Medisch Centrum, Ikazia Hospital, Rotterdam
- Responsible party
- Sponsor
- Investigators
- Dorien Kiers, MD, PhD, Principal investigator, Franciscus Gasthuis & Vlietland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084117
- Sponsor's protocol ID
- HiCAP
- Acronym
- HiCAP
- Status last verified
- Aug 2025
- First submitted
- 2 Oct 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06084117
- Acronym / sponsor ID
- HiCAP / HiCAP
- Conditions
- Acute Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Reinier de Graaf Groep, Haga Medisch Centrum, Ikazia Hospital, Rotterdam
- Study start
- 14 May 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot randomized unblinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Oxygen (HFNO) | Experimental | Other: HFNOPatients 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). |
| Non-Invasive Ventilation (NIV) | Active comparator | Other: NIVPatients 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% |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNORespiratory support with HFNO (as opposed to NIV, as per standard of care) | Other | High Flow Nasal Oxygen (HFNO) |
| NIVRespiratory support with Non-invasive ventilation, standard of care | Other | Non-Invasive Ventilation (NIV) |
Primary outcome
feasilibity to perform a larger RCT inclusion rate
Time frame: 1 year
Inclusion rate
feasibility to perform a larger RCT screening rate
Time frame: 1 year
Screening rate
feasibility to perform a larger RCTperceived
Time frame: 1 year
perceived feasibility as qualified by staff and nurses
feasibility to perform a larger RCT protocol deviations
Time frame: 1 year
protocol deviations
37 secondary outcomes
Treatment failure
Time frame: 30 days
duration of intervention
Time frame: 30 days
need for sedation
Time frame: untill end of ICU admission
heart rate
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
respiratory rate
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood pressure
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
SpO2
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
blood gas
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
dyspnea score
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Clinical Parameters
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
consciousness
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
agitation and sedation level
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
secretions
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters flow
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters FiO2
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HFNO ventilatory support parameters temperature
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PEEP
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters PS
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
NIV ventilatory support parameters: FiO2
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
(dys)comfort score
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
HACOR score
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
facial pressure sores
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
nursing effort
Time frame: first 6 hours of study
nursing effort VAS
Time frame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
30d mortality
Time frame: 30 days
90d mortality
Time frame: 90 days
90d quality of life EQ5D
Time frame: 90 days
90d quality of life SF36
Time frame: 90 days
90d anxiety and depression
Time frame: 90 days
90d PTDS
Time frame: 90 days
90d PTSD
Time frame: 90 days
90d dyspnea CCQ
Time frame: 90 days
90d dyspnea MRC
Time frame: 90 days
need for intubation and mechanical ventilation
Time frame: during ICU admission
need for switch to other modality
Time frame: during ICU admission
reason of treatment failure
Time frame: during ICU admission
expression of treatment failure
Time frame: during ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorien Kiers, MD, PhD principal investigator
Franciscus Gasthuis & Vlietland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNO and NIV in people with Acute Exacerbation of COPD, run by Franciscus Gasthuis at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorien Kiers, MD, PhD (+3110 461 6161, d.kiers@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasilibity to perform a larger RCT inclusion rate (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.