Investigation of strategies for perioperative improvement of lung function in patients with morbid obesity: individualized intraoperative ventilation with following postoperative continuous CPAP support

Not Applicable

Recruiting

• Conditions: E66.9; Obesity, unspecified

• Registration Number: DRKS00013984
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 54

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial oxygenation (quotient of arterial oxygen partial pressure and inspiratory oxygen fraction, PaO2 / FiO2) 2 hours after extubation. <br>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 Outcome Measures

Name	Time	Method
• PaO2 / FiO2 2 hours after extubation compared between the CPAP and the FiO2 = 0.5 arm<br>• PaO2 / FiO2 4 hours after extubation (CPAP vs FiO2 = 0.5 and compared to 2 hours value)<br>• End-expiratory lung volume (EELV)<br>• Postoperative pulmonary and non-pulmonary organ function (Sequential Organ Failure Assessment Scores)<br>• the duration of intensive care unit and hospital stay in days.