E66.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - age >= 18 years - BMI = 35 kg/m² - need for surgery with intermediate or high risk for post–perative pulmonary complications (ARISCAT score higher than or equal to 26) - Written informed consent
Exclusion criteria
Exclusion criteria: - Need for neurosurgery, cardiothoracic, head, neck and liver surgery - Persistent hemodynamic instability - History of previous severe chronic obstructive pulmonary disease (COPD) or acute lung injury - severe cardiac disease (NYHA III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmias) - Neuromuscular disease of all types - Surgery longer than 30 minutes within last 30 days of all types - cardiac peacemaker or other implanted stimulation devices - Pregnancy (excluded by laboratory analysis) - Participation in other interventional clinical trials according to AMG or MPG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial oxygenation (quotient of arterial oxygen partial pressure and inspiratory oxygen fraction, PaO2 / FiO2) 2 hours after extubation. The CPAP arm of the ADIPO-CPAP-study and the EIT arm of the obese patients from the previous Adipo-Vent-study are compared | — |
Secondary
| Measure | Time frame |
|---|---|
| • PaO2 / FiO2 2 hours after extubation compared between the CPAP and the FiO2 = 0.5 arm • PaO2 / FiO2 4 hours after extubation (CPAP vs FiO2 = 0.5 and compared to 2 hours value) • End-expiratory lung volume (EELV) • Postoperative pulmonary and non-pulmonary organ function (Sequential Organ Failure Assessment Scores) • the duration of intensive care unit and hospital stay in days. | — |
Countries
Germany
Contacts
Klinik und Poliklinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Leipzig AöR