lung complications after surgery Postoperative pulmonary complications Lung complications after surgery
Conditions
Interventions
An individualized high PEEP with recruitment maneuvers ventilation strategy,
targeting a low driving pressure will be compared to a standard low PEEP
without recruitment maneuvers during intraoperat
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this trial, a patient must meet the following criteria: 1. age above 18 years; 2. scheduled for minimally invasive abdominal surgery; AND 3. increased (i.e., intermediate or high) risk of PPCs according to the ARISCAT risk score (26 or more points); OR 4. the combination of age above 40 years, scheduled surgery lasting more than 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; 5. signed written informed consent
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this trial: 1. planned for open abdominal surgery; 2. planned for surgery in lateral or prone position; 3. planned for combined abdominal and intra-thoracic surgery 4. confirmed pregnancy; 5. consent for another interventional trial during anesthesia; 6. having received invasive ventilation > 30 minutes within the last five days; 7. any previous lung surgery; 8. history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD; 9. history of acute respiratory distress syndrome (ARDS); 10. expected to require postoperative ventilation; 11. expected hemodynamic instability or intractable shock; 12. severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia*s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite of PPCs in the first 5 postoperative days - Mild respiratory failure - Severe respiratory failure - Bronchospasm - Pneumonia - Aspiration pneumonitis - Atelectasis - Acute respiratory distress syndrome (ARDS) - Pleural effusion - Cardiopulmonary edema - Pneumothorax | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative complications including: - Desaturation - Hypotension - Increased need for vasoactive medications - New arrhytmias needing intervention Impaired wound healing Postoperative extrapulmonary complications - Sepsis - Septic shock - Extra-pulmonary infection - Acute renal insufficiency Impaired wound healing Intra-operative fluid strategy All cause mortality at day 5, 30 and 90 Cost-effectiveness variables - Postoperative supplementary oxygen need - Use of antibiotics for pneumonia - Need for thoracic imaging - Length of hospital stay - Need of ICU admission and corresponding lenth of ICU stay - Unplanned admission to an intenvise care unit (ICU) and lenght of stay on ICU - Length of hospital stay | — |
Countries
Austria, Germany, Italy, Netherlands, Spain
Contacts
Public ContactM.W. Hollmann
Amsterdam UMC
Outcome results
None listed