High Flow Nasal Oxygen for Exacerbation COPD
- Conditions
- Acute Exacerbation of COPD
- Interventions
- Other: NIVOther: HFNO
- Registration Number
- NCT06084117
- Lead Sponsor
- Franciscus Gasthuis
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Invasive Ventilation (NIV) NIV 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% High Flow Nasal Oxygen (HFNO) HFNO 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).
- Primary Outcome Measures
Name Time Method feasibility to perform a larger RCT protocol deviations 1 year protocol deviations
feasibility to perform a larger RCTperceived 1 year perceived feasibility as qualified by staff and nurses
feasilibity to perform a larger RCT inclusion rate 1 year Inclusion rate
feasibility to perform a larger RCT screening rate 1 year Screening rate
- Secondary Outcome Measures
Name Time Method SpO2 at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge peripheral saturation by pulsoxymeter (in %)
90d dyspnea MRC 90 days MRC
reason of treatment failure during ICU admission reason of treatment failure: clinical deterioration, failure to improve, other.
90d mortality 90 days mortality
90d anxiety and depression 90 days HADS
Treatment failure 30 days cross-over, invasive mechanical ventilation, death
need for sedation untill end of ICU admission use of sedatives, and type of sedation
heart rate at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge beats per minute
respiratory rate at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge breaths per minute
blood pressure at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge systolic and diastolic pressure in mmHg
consciousness at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge glasgow coma scale (EMV)
agitation and sedation level at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge Richmond Agitation and Sedation scale (RASS)
(dys)comfort score at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge 10 point VAS scale
HACOR score at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge calculated from abovementioned parameters (pH, conciousness, PaO2/Fio2, respiratory rate)
blood gas at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge with pH, PO2, PCO2, bicarbonate
Clinical Parameters at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge heart rate, respiratory rate, blood pressure, Spo2, arterial blood gas, dyspnea score, glasgow coma scale, RASS, seceretions
HFNO ventilatory support parameters temperature at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge temperature in Celcius
duration of intervention 30 days time of respiratory support
dyspnea score at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge Borg dyspnea score (0-10 on VAS)
secretions at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge (as 0 (absent), 1 (low quantity), 2 (intermediate), 3 (abundant), or 4 (very abundant) little to normal/abundant)
need for intubation and mechanical ventilation during ICU admission intubation
NIV ventilatory support parameters PEEP at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge PEEP in cmH2O
NIV ventilatory support parameters PS at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge PS in cmH2O
NIV ventilatory support parameters: FiO2 at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge FiO2 in %
30d mortality 30 days mortality
90d quality of life EQ5D 90 days EQ5D
90d quality of life SF36 90 days SF-36
HFNO ventilatory support parameters flow at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge flow in L/min
HFNO ventilatory support parameters FiO2 at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge FiO2 in %
facial pressure sores at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge scored daily: yes or no, and if yes: grade 1-4
nursing effort first 6 hours of study respiratory support interventions per 2 hour by peat list
nursing effort VAS at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge experienced nursing effort at a VAS scale from 1-10
90d PTDS 90 days IES-R
90d PTSD 90 days IES-R
90d dyspnea CCQ 90 days CCQ
expression of treatment failure during ICU admission worsening of pH, PaCO2, respiratory rate, consiousness, agitation/discomfort, other
need for switch to other modality during ICU admission cross over to NIV from HFNO or from HFNO to NIV
Trial Locations
- Locations (4)
Franciscus Gasthuis & Vlietland
🇳🇱Rotterdam, Netherlands
Ikazia
🇳🇱Rotterdam, Netherlands
Haaglanden Medisch Centrum
🇳🇱Den Haag, Netherlands
Reinier de Graaf
🇳🇱Delft, Netherlands