High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease. (HicaP)

High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease. (HicaP) - HFNO in COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53264

Enrollment

Registered

2023-03-08

Start date

2024-05-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

HFNO versus NIV as first line treatment at presentation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Metabolic (component of) acidosis, defined as a bicarbonate

Design outcomes

Primary

Measure	Time frame
Feasibility: screening rate, inclusion rate, feasibility as qualified by staff and nurses.	—

Secondary

Measure	Time frame
• 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).	—

Measure

Time frame

• 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).

—

Countries

Netherlands

Contacts

Public ContactHD Kiers

Franciscus

d.kiers@franciscus.nl010-4616418

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026