Mechanical ventilation in patients with severe diseases of the lungs
Conditions
Interventions
Automated control of inspired oxygen in mechanically ventilated patients.
Group 2: Control group
manual control of inspired oxygen fraction in mechanically ventilated patients.
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Intubated or tracheotomized patients requiring mechanical ventilation at 9:00 a.m. (study round) for longer than 9 hours •Positive presumed will regarding study participation
Exclusion criteria
Exclusion criteria: •Known pregnancy •Incapability of peripheral oxygen saturation measurement •No noticeable pulsatile plethysmography curve •Clinical indication for hyperoxia (SpO2-target > 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 | — |
Countries
Germany
Contacts
Public ContactDirk Schädler
Universitätsklinikum Schleswig-Holstein
Outcome results
None listed