Automated control of inspired oxygen fraction in mechanically ventilated patients - a single-center randomized controlled trial

Automated control of inspired oxygen fraction in mechanically ventilated patients - a single-center randomized controlled trial - ATOXYVENT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028167

Enrollment

Registered

2023-10-09

Start date

2023-10-10

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

Critically ill patients receiving invasive mechanical ventilation

Interventions

Group 1: Automated control of inspired fraction of oxygen during mechanical ventilation Group 2: Manual control of the inspired fraction of oxygen during mechanical ventilation on the intesive care un

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Intubated or tracheostomized patients requiring mechanical ventilation at 9:00 a.m. for longer than 9 hours • Positive presumed will regarding study participation

Exclusion criteria

Exclusion criteria: • Age 96%) • Negative presumed will regarding study participation • Expected extubation within the next 24 hours

Design outcomes

Primary

Measure	Time frame
Proportion of time in target zone for peripheral oxygen saturation within the first 24 hours following randomization.	—

Secondary

Measure	Time frame
• Proportion of time with automated control of inspired fraction of oxygen in intervention group • Cumulative duration of episodes with hypoxia according to pulse oximetry (SpO2 98%) • Number of blood gas samples with hypoxia (PaO2 110 mmHg) • Number of changes of inspired fraction of oxygen • Number and reasons of self-aborts of the automated system • Number and reasons of user-aborts of the automated system • Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypoxemic respiratory failure • Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypercapnic respiratory failure • Ventilator-free days alive at day 28d • ICU mortality	—

Measure

Time frame

• Proportion of time with automated control of inspired fraction of oxygen in intervention group • Cumulative duration of episodes with hypoxia according to pulse oximetry (SpO2 98%) • Number of blood gas samples with hypoxia (PaO2 110 mmHg) • Number of changes of inspired fraction of oxygen • Number and reasons of self-aborts of the automated system • Number and reasons of user-aborts of the automated system • Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypoxemic respiratory failure • Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypercapnic respiratory failure • Ventilator-free days alive at day 28d • ICU mortality

—

Countries

Germany

Contacts

Public ContactDirk Schädler

Universitätsklinikum Schleswig-Holstein, Campus Kiel

dirk.schaedler@uksh.de+49 431 500 20801

Outcome results

None listed

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