Comparison of different recruitment manoeuvres during general anaesthesia in obese patients.

Not Applicable

Recruiting

• Conditions: E66.2; Extreme obesity with alveolar hypoventilation

• Registration Number: DRKS00032147
• Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Patients undergoing surgery under general anaesthesia (intubation anaesthesia).
- Moderate to high risk of postoperative pulmonary complications (ARISCAT score = 26).
- BMI = 40 kg/m2
- Expected duration of intubation = 2 hours

Exclusion Criteria

- Previous lung surgery (any)
- Persistent haemodynamic instability
- Known severe COPD (non-invasive ventilation and/or long-term oxygen therapy, repeated systemic corticosteroids due to repeated exacerbations)
- Immunosuppressive medication or radiotherapy within the last 2 months before inclusion
- Heart failure = NYHA III, acute coronary syndrome
- Pregnancy (exclusion by history or laboratory test)
- ARDS
- Severe pulmonary arterial hypertension, defined as systolic pulmonary arterial pressure > 40 mmHg
- Elevated intracranial pressure
- Any neuromuscular disease
- Implanted cardiac assist devices, pacemakers or ICDs
- Intraoperative prone or lateral positioning
- Procedures with single lung ventilation
- Cardiac surgery
- Neurosurgical procedures
- Inclusion in other interventional study according to AMG/MDPG or lack of consent to participate in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delta EELV (measured by EIT) 1 minute after the recruitment manoeuvre 30 minutes after induction of anaesthesia and intubation (T2) compared to the time point 1 minute after induction of anaesthesia and intubation (T1).

Secondary Outcome Measures

Name	Time	Method
• Delta EELV 1 min after recruitment manoeuvre 10 min after intubation (T1)<br>• Delta EELV 1 minute after the recruitment manoeuvre 60 min after intubation (T3)<br>• Delta EELV 1 minute after recruitment manoeuvre 120 min intubation (T4)<br>• Percentage distribution of tidal volume in ventral and dorsal lung segments at time points T1, T2, T3 and T4<br>• Atelectasis formation at time points T1, T2 and T3 and 30 min after arrival in the recovery room/intensive care unit (T4), measured by sonography (Lung Ultrasonography Score)<br>• PaO2/FiO2 at time points T1, T2, T3<br>• Complications associated with the recruitment manoeuvre<br>- Hypotension (defined as systolic arterial blood pressure < 90mmHg for > 2 min)<br>- Bradycardia (defined as heart rate < 40/min).<br>- Vasopressor consumption during the recruitment manoeuvre<br>- Postoperative respiratory insufficiency (oxygen demand in recovery room/intensive care unit, non-invasive ventilation, unplanned reintubation.