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

Not Applicable

Conditions: J96.9
J96.0
Respiratory failure, unspecified
Acute respiratory failure

Registration Number: DRKS00034597

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 150

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

- Age = 18 years
- Pregnancy
- Expected or present dyshemoglobinemia
- Poor signal quality of SpO2 measurement at finger and ear (quality index < 60%)
- Haemodynamic instability (noradrenaline or adrenaline with a necessary continuous infusion of > 1 mg/h)
- Severe respiratory acidosis with pH < 7.25
- Difference between SpO2 and SaO2 of more than 5%

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of time spent with SpO2 below the prescribed range during the HFOT observation period.

Secondary Outcome Measures

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