High Flow Nasal Oxygen for Exacerbation COPD
ConditionAcute Exacerbation of COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorFranciscus Gasthuis
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
HFNO
Other interventionRespiratory support with HFNO (as opposed to NIV, as per standard of care)
NIV
Other interventionRespiratory support with Non-invasive ventilation, standard of care
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: High Flow Nasal Oxygen (HFNO)Experimental treatment 1 intervention
Group B: Non-Invasive Ventilation (NIV)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
feasilibity to perform a larger RCT inclusion rate
Inclusion rate
Time frame
1 year2
feasibility to perform a larger RCT screening rate
Screening rate
Time frame
1 year3
feasibility to perform a larger RCTperceived
perceived feasibility as qualified by staff and nurses
Time frame
1 year4
feasibility to perform a larger RCT protocol deviations
protocol deviations
Time frame
1 yearSecondary outcomes
1
Treatment failure
cross-over, invasive mechanical ventilation, death
Time frame
30 days2
duration of intervention
time of respiratory support
Time frame
30 days3
need for sedation
use of sedatives, and type of sedation
Time frame
untill end of ICU admission4
heart rate
beats per minute
Time frame
at start, 1, 2, 6, 12, 24 and every 24 hours untill dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Franciscus Gasthuis
Lead sponsor
Reinier de Graaf Groep
Collaborator
Haga Medisch Centrum
Collaborator
Ikazia Hospital, Rotterdam
Collaborator
Source ClinicalTrials.gov