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ComfortVent-CO2Pilot: Comparing Optimal Modes For Non-Invasive Ventilation In High CO2 - a Pilot Randomized Crossover Study

ComfortVent-CO2Pilot: Comparing Optimal Modes For Non-Invasive Ventilation In High CO2 - a Pilot Randomized Crossover Study - ComfortVent-CO2Pilot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037447
Enrollment
20
Registered
2025-07-16
Start date
2025-07-24
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Hypercapnic respiratory failure

Interventions

Sponsors

Klinik für Anästhesiologie und Operative Intensivmedizin Universitätsklinikum Schleswig-Holstein, Campus Kiel
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients in intensive care units/ICU wards with hypercapnia (PaCO2 or PkapCO2 >45 mmHg) and clinical indication for non-invasive ventilation - Age over 18 years - Consent to study participation by the patient

Exclusion criteria

Exclusion criteria: - GCS < 14 - Lack of ability to give consent or communicate - Acute respiratory distress syndrome (ARDS) according to Berlin definition - Pulmonary fibrosis - Contraindications for non-invasive ventilation, such as facial injuries, upper airway obstructions, lack of protective reflexes, recurrent vomiting, ileus, allergies to mask or EIT belt components - PaO2/FiO2 ratio = 100 mmHg or SpO2/FiO2 ratio = 148 (with SpO2 = 97%) - Neither arterial access nor valid SpO2 measurement available - Thoracic injuries: unrelieved pneumothorax, open wounds of the thorax None of the above exclusion criteria may be met if a patient is to be included in the study.

Design outcomes

Primary

MeasureTime frame
Patient comfort (numeric rating scale)

Secondary

MeasureTime frame
- Number of patients with = 2h NIV tolerance - Patient comfort (external assessment) - Leakage volume - ABG parameters: PaO2 or PkapO2, PaCO2 or PkapCO2, pH value - Regional ventilation distribution and change in end-expiratory lung volume, determined using electrical impedance tomography (EIT) - Vital parameters: Respiratory rate, heart rate, blood pressure, SpO2 - respiratory minute volume - mechanical power of ventilation

Countries

Germany

Contacts

Public ContactTobias Becher

Klinik für Anästhesiologie und Operative Intensivmedizin Universitätsklinikum Schleswig-Holstein, Campus Kiel

tobias.becher@uksh.de+49 431 50020980

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026