High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
Reinier de Graaf
NOT_YET_RECRUITING
Delft
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Ikazia
NOT_YET_RECRUITING
Rotterdam
Haaglanden Medisch Centrum
NOT_YET_RECRUITING
The Hague
Contact Information
Primary
Dorien Kiers, MD, PhD
d.kiers@franciscus.nl
+3110 461 6161
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
Experimental: High Flow Nasal Oxygen (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).
Active_comparator: Non-Invasive Ventilation (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%
Related Therapeutic Areas
Sponsors
Collaborators: Ikazia Hospital, Rotterdam, Haga Medisch Centrum, Reinier de Graaf Groep
Leads: Franciscus Gasthuis