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High flow oxygen therapy with automatic closed-loop controlled oxygen titration in hypoxemic respiratory failure: a randomized-controlled trial.

High flow oxygen therapy with automatic closed-loop controlled oxygen titration in hypoxemic respiratory failure: a randomized-controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034597
Enrollment
150
Registered
2024-07-03
Start date
2024-12-19
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

J96.9 J96.0

Interventions

Group 1: Patients randomized to the intervention group receive high-flow oxygen therapy starting at 40 L/min. The inspiratory oxygen fraction is automatically set on the ventilator based on the derive

Sponsors

Klinik für Anästhesiologie, operative Intensivmedizin und Schmerzmedizin, Universitätsmedizin Mannheim
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with hypoxemic respiratory failure admitted to IMC ward 37-4 or ICU 32-3 - Need for HFOT with = 40 L/min with a FiO2 = 0.30 - HFOT foreseeable on admission for at least 24 hours

Exclusion criteria

Exclusion criteria: - Age = 18 years - Pregnancy - Expected or present dyshemoglobinemia - Poor signal quality of SpO2 measurement at finger and ear (quality index 1 mg/h) - Severe respiratory acidosis with pH < 7.25 - Difference between SpO2 and SaO2 of more than 5%

Design outcomes

Primary

MeasureTime frame
Proportion of time spent with SpO2 below the prescribed range during the HFOT observation period.

Secondary

MeasureTime frame
- Proportion of time during which the patient's SpO2 is higher than the defined SpO2 target during high-flow oxygen therapy. - Proportion of time in which the patient's SpO2 is outside the defined SpO2 target during high-flow oxygen therapy.  - Workload for caregivers, assessed by o Number of manual changes in FiO2 o Number of alarms caused by hypoxia or hyperoxia - Total amount of oxygen consumed by the patient - Severity of respiratory distress and patient comfort - If postoperative: rate of anastomotic insufficiencies - HFOT failure with need for invasive or non-invasive ventilation - Variability of the SpO2/FiO2 ratio over time - Retrospective segmentation of CT imaging

Countries

Germany

Contacts

Public ContactJörg Krebs

Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerzmedizin, Universitätsmedizin Mannheim

joerg.krebs@umm.de+496213833233

Outcome results

None listed

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