Clinical trial NCT06084117: High Flow Nasal Oxygen for Exacerbation COPD
Official title: High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Exacerbation of COPD
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
Collaborators: name: Reinier de Graaf Groep
name: Haga Medisch Centrum
name: Ikazia Hospital, Rotterdam
First posted: 2023-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot randomized unblinded controlled trial
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: feasilibity to perform a larger RCT inclusion rate
timeFrame: 1 year
measure: feasibility to perform a larger RCT screening rate
timeFrame: 1 year
measure: feasibility to perform a larger RCTperceived
timeFrame: 1 year
measure: feasibility to perform a larger RCT protocol deviations
timeFrame: 1 year
Secondary outcomes:
measure: Treatment failure
timeFrame: 30 days
measure: duration of intervention
timeFrame: 30 days
measure: need for sedation
timeFrame: untill end of ICU admission
measure: heart rate
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: respiratory rate
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: blood pressure
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: SpO2
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: blood gas
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: dyspnea score
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: Clinical Parameters
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: consciousness
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: agitation and sedation level
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: secretions
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: HFNO ventilatory support parameters flow
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: HFNO ventilatory support parameters FiO2
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: HFNO ventilatory support parameters temperature
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: NIV ventilatory support parameters PEEP
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: NIV ventilatory support parameters PS
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: NIV ventilatory support parameters: FiO2
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: (dys)comfort score
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: HACOR score
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: facial pressure sores
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: nursing effort
timeFrame: first 6 hours of study
measure: nursing effort VAS
timeFrame: at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
measure: 30d mortality
timeFrame: 30 days
measure: 90d mortality
timeFrame: 90 days
measure: 90d quality of life EQ5D
timeFrame: 90 days
measure: 90d quality of life SF36
timeFrame: 90 days
measure: 90d anxiety and depression
timeFrame: 90 days
measure: 90d PTDS
timeFrame: 90 days
measure: 90d PTSD
timeFrame: 90 days
measure: 90d dyspnea CCQ
timeFrame: 90 days
measure: 90d dyspnea MRC
timeFrame: 90 days
measure: need for intubation and mechanical ventilation
timeFrame: during ICU admission
measure: need for switch to other modality
timeFrame: during ICU admission
measure: reason of treatment failure
timeFrame: during ICU admission
measure: expression of treatment failure
timeFrame: during ICU admission
Other outcomes:
Locations:
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Ikazia
Study officials:
affiliation: Franciscus Gasthuis & Vlietland
name: Dorien Kiers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: