ComfortVent-O2Pilot: Comparing Optimal Modes For Non-Invasive Ventilation In Low O2 - a Pilot Randomized Crossover Study

ComfortVent-O2Pilot: Comparing Optimal Modes For Non-Invasive Ventilation In Low O2 - a Pilot Randomized Crossover Study - ComfortVent-O2Pilot

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037429

Enrollment

Registered

2025-07-16

Start date

2025-07-24

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Hypoxic respiratory failure

Interventions

Group 1: First ventilation mode: BiLevel-NRV Group 2: First ventilation mode: mandatorisches BiLevel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients in intensive care units/ICU wards with indication for non-invasive ventilation due to hypoxia (PaO2/FiO2 = 300 mmHg or SpO2/FiO2 = 315 at SpO2 = 97 %)) - Age =18 years - Consent to study participation by the patient

Exclusion criteria

Exclusion criteria: - GCS 45 mmHg

Design outcomes

Primary

Measure	Time frame
Patient comfort (Numeric Rating Scale)	—

Secondary

Measure	Time 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 - Power of mechanical ventilation	—

Measure

Time 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 - Power of mechanical 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: May 1, 2026