Reduction of ventilation invasiveness through combined organ support

Phase 4

• Conditions: J96; N17; Respiratory failure, not elsewhere classified; Acute renal failure

• Registration Number: DRKS00015874
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

invasive controlled ventilation at acute hypercapnic respiratory failure (PaCO2 > 45 mmHg)
- tidal volume > 6ml/kg ideal weight or driving pressure difference (delta p) > 15 cmH2O required to reach a pH value > 7,30
- acute renal failure (KDIGO II or III)
- clinical indication for continuous venovenous haemodialysis
- consent to participate in the clinical trial

Exclusion Criteria

- severe acute hypoxemic respiratory failure (PaO2/FiO2 ratio < 100 mmHg)
- moribund status (clinical evaluation)
- gravidity
- severe haemodynamic instability (heart rate < 40 bpm or > 150 bpm or mean arterial pressure < 65 mmHg or cardiac output < 5 l/min despite adequate therapy)
- elevated intracranial pressure

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tidal volume (ml/kg ideal weight) to reach a ventilation with a pH value >7,30 and PaCO2 < 60 mmHg (measured 6 hours after the beginning of the ADVOS treatment)

Secondary Outcome Measures

Name	Time	Method
- CO2 removal achieved with the ADVOS system (ml/min)<br>- required alveolar ventilation per minute (l/min)<br>- pressure difference between airway plateau pressure and PEEP (cmH2O)<br>- change of power of ventilation (Joule/min)<br>- partial pressure of oxygen (mmHg)<br>- partial pressure of carbon dioxide (mmHg)<br>- pH