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

Not Applicable

Recruiting

Conditions: Critically ill patients receiving invasive mechanical ventilation

Registration Number: DRKS00028167

Lead Sponsor: niversitätsklinikum Schleswig-Holstein, Campus Kiel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

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

•Age <18 yrs.
•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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of time in target zone for peripheral oxygen saturation within the first 24 hours following randomization.

Secondary Outcome Measures

Name	Time	Method
•Proportion of time with automated control of inspired fraction of oxygen in intervention group<br>•Cumulative duration of episodes with hypoxia according to pulse oximetry (SpO2 < 90%)<br>•Cumulative duration of episodes with hyperoxia according to pulse oximetry (SpO2 > 98%)<br>•Number of blood gas samples with hypoxia (PaO2 < 60 mmHg)<br>•Number of blood gas samples with hyperoxia (PaO2 > 110 mmHg)<br>•Number of changes of inspired fraction of oxygen<br>•Number and reasons of self-aborts of the automated system<br>•Number and reasons of user-aborts of the automated system<br>•Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypoxemic respiratory failure<br>•Proportion of time in target zone for peripheral oxygen saturation in the subgroup of patients with acute hypercapnic respiratory failure<br>•Ventilator-free days alive at day 28d<br>•ICU mortality<br>