To assess the feasibility of a larger study comparing HFNO with NIV as first line treatment in hypercapnic, acidotic AECOPD.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility: screening rate, inclusion rate, feasibility as qualified by staff
and nurses.
Secondary outcome
• Treatment failure:
* Treatment with another modality (HFNO or NIV) (cross-over)
* Invasive mechanical ventilation
* Death
o Reason of failure: clinical deterioration or failure to improve (as described
in section 3.5), / treatment intolerance / other
o Expression of failure: worsening of pH, PaCO2, respiratory rate,
consciousness, agitation/discomfort, other
• Duration of intervention
• Data to be collected at start, 1 hour, 2 hours and 6 hours (all +- 30
minutes) and 12, 24, 48 hours (+- 60 minutes), during ICU admission.
o Need for sedation (yes/no)
* type of sedation (e.g. dexmedetomedine, clonidine, propofol, opioids,
benzodiazepines, other)
* duration of sedation
o Clinical parameters
* heart rate, respiratory rate, blood pressure, SpO2
* arterial blood gas (pH, PaO2, PaCO2, SpO2, bicarbonate, base excess, lactate)
* dyspnea score (Borg score 0-10)
* Glasgow Coma Scale
* RASS
* Secretions (as 0 (absent), 1 (low quantity), 2 (intermediate), 3 (abundant),
or 4 (very abundant) little to normal/abundant)
o Ventilatory support parameters to be collected
* HFNO: flow, FiO2 and temperature
* NIV: PEEP/EPAP, PS/IPAP, FiO2,
o (dys)comfort score on a 10-point VAS scale (0 = comfortable, 10= most
discomfort imaginable).
o HACOR score (calculated from the abovementioned parameters)
• Facial pressure sores (scored daily: yes/no, severity 1-4)
• Nursing effort:
o Number of nursing respiratory support interventions (peat list per
intervention) per 2 hours for the first 6 hours.
• 30 day mortality
• 90 day mortality
• At 90 days: questionnaire on quality of life (EQ5D and SF-36), anxiety and
depression (HADS), PTSD (IES-R) and dyspnea (CCQ and MRC).
Background summary
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. We hypothesise 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.
Study 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
Intervention
HFNO versus NIV as first line treatment at presentation
Study burden and risks
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. We will ask permission
of the patient 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.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
• Known chronic obstructive pulmonary disease
• Acute hypercapnic exacerbation of this condition, defined as:
o PaCO2>45 mmHg or >6.0 kPa
o pH 7.25-7.34
• Age >40 years
Exclusion criteria
- Metabolic (component of) acidosis, defined as a bicarbonate <20 mmol/L.
- Non-invasive respiratory support (either NIV or HFNO) already started, e.g.
by ambulance or on the ward.
• 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.
cognitive impairment, psychological or mental inabilities).
• 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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84019.100.23 |