High Flow Nasal Oxygen for Exacerbation COPD

Acute Exacerbation of COPD Clinical Trial

— HiCAP  

Official title:

High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084117
• Other study ID #: HiCAP
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: Franciscus Gasthuis
• Contact: Dorien Kiers, MD, PhD
• Phone: +3110 461 6161
• Email: d.kiers[@]franciscus.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation of COPD

Intervention

Other:
• HFNO
Respiratory support with HFNO (as opposed to NIV, as per standard of care)
• NIV
Respiratory support with Non-invasive ventilation, standard of care

Locations

Country	Name	City	State
Netherlands	Reinier de Graaf	Delft
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam
Netherlands	Ikazia	Rotterdam

Sponsors (4)

Lead Sponsor	Collaborator
Franciscus Gasthuis	Haga Medisch Centrum, Ikazia Hospital, Rotterdam, Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasilibity to perform a larger RCT inclusion rate	Inclusion rate	1 year
Primary	feasibility to perform a larger RCT screening rate	Screening rate	1 year
Primary	feasibility to perform a larger RCTperceived	perceived feasibility as qualified by staff and nurses	1 year
Primary	feasibility to perform a larger RCT protocol deviations	protocol deviations	1 year
Secondary	Treatment failure	cross-over, invasive mechanical ventilation, death	30 days
Secondary	duration of intervention	time of respiratory support	30 days
Secondary	need for sedation	use of sedatives, and type of sedation	untill end of ICU admission
Secondary	heart rate	beats per minute	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	respiratory rate	breaths per minute	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	blood pressure	systolic and diastolic pressure in mmHg	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	SpO2	peripheral saturation by pulsoxymeter (in %)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	blood gas	with pH, PO2, PCO2, bicarbonate	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	dyspnea score	Borg dyspnea score (0-10 on VAS)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	Clinical Parameters	heart rate, respiratory rate, blood pressure, Spo2, arterial blood gas, dyspnea score, glasgow coma scale, RASS, seceretions	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	consciousness	glasgow coma scale (EMV)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	agitation and sedation level	Richmond Agitation and Sedation scale (RASS)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	secretions	(as 0 (absent), 1 (low quantity), 2 (intermediate), 3 (abundant), or 4 (very abundant) little to normal/abundant)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	HFNO ventilatory support parameters flow	flow in L/min	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	HFNO ventilatory support parameters FiO2	FiO2 in %	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	HFNO ventilatory support parameters temperature	temperature in Celcius	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	NIV ventilatory support parameters PEEP	PEEP in cmH2O	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	NIV ventilatory support parameters PS	PS in cmH2O	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	NIV ventilatory support parameters: FiO2	FiO2 in %	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	(dys)comfort score	10 point VAS scale	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	HACOR score	calculated from abovementioned parameters (pH, conciousness, PaO2/Fio2, respiratory rate)	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	facial pressure sores	scored daily: yes or no, and if yes: grade 1-4	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	nursing effort	respiratory support interventions per 2 hour by peat list	first 6 hours of study
Secondary	nursing effort VAS	experienced nursing effort at a VAS scale from 1-10	at start, 1, 2, 6, 12, 24 and every 24 hours untill discharge
Secondary	30d mortality	mortality	30 days
Secondary	90d mortality	mortality	90 days
Secondary	90d quality of life EQ5D	EQ5D	90 days
Secondary	90d quality of life SF36	SF-36	90 days
Secondary	90d anxiety and depression	HADS	90 days
Secondary	90d PTDS	IES-R	90 days
Secondary	90d PTSD	IES-R	90 days
Secondary	90d dyspnea CCQ	CCQ	90 days
Secondary	90d dyspnea MRC	MRC	90 days
Secondary	need for intubation and mechanical ventilation	intubation	during ICU admission
Secondary	need for switch to other modality	cross over to NIV from HFNO or from HFNO to NIV	during ICU admission
Secondary	reason of treatment failure	reason of treatment failure: clinical deterioration, failure to improve, other.	during ICU admission
Secondary	expression of treatment failure	worsening of pH, PaCO2, respiratory rate, consiousness, agitation/discomfort, other	during ICU admission