Postoperative Complications, Surgery
Conditions
Keywords
Minimally invasive abdominal surgery, Mechanical ventilation, Positive end-expiratory pressure, Driving pressure, Postoperative pulmonary complications, Recruitment maneuver
Brief summary
The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.
Interventions
PROCEDUREIntraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial
Sponsors
Onze Lieve Vrouwe Gasthuis
HagaZiekenhuis
Dijklander Ziekenhuis
The Netherlands Cancer Institute
Isala
Maasstad Hospital
Medisch Spectrum Twente
University Medical Center Groningen
Leiden University Medical Center
Hospital Universitario La Fe
Ospedale Policlinico San Martino
University Hospital Carl Gustav Carus
Medical University Innsbruck
Spaarne Gasthuis
Zaans Medical Center
Alrijne Hospital
Albert Schweitzer Hospital
Maastricht University Medical Center
Noordwest Ziekenhuisgroep
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. age \> 18 years; AND 2. scheduled for minimally invasive abdominal surgery; AND 3. at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age \> 40 years, scheduled surgery lasting \> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND 4. signed written informed consent
Exclusion criteria
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 | Description |
|---|---|---|
| Proportion of participants developing one or more postoperative pulmonary complications (PPCs) | The first 5 postoperative days | A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fluid strategy | During general anesthesia | Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products |
| Impaired wound healing | The first 5 postoperative days | Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician; |
| Postoperative extrapulmonary complications | The first 5 postoperative days | Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure |
| Mortality | Postoperative day 5, day 30 and day 90 | All-cause mortality at day 5, day 30 and 90, and in-hospital mortality |
| Intraoperative complications | For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours | Including: any episode of desaturation; any episode of hypotension; any need for vasoactive agents, either as bolus or continuous administration, defined as more than needed to compensate for vasodilating effects of anesthesia as judged by the attending anesthesiologist and any new arrhythmias needing intervention |
| Oxygen use | The first 5 postoperative days | Postoperative supplemental oxygen use (days). Presence, duration and levels of postoperative supplemental oxygen |
| Antibiotics use | The first 5 postoperative days | Use of antibiotics for pneumonia (proportion of patients who received antibiotics) |
| Thoracic imaging | The first 5 postoperative days | Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging. |
| Length of stay | Postoperatively until the end of the 90 day follow-up period | Length of hospital stay (days); length of ICU admission if applicable (days); |
Countries
Netherlands
Contacts
Primary ContactTom Vermeulen, MD
Backup ContactGalina Dorland, MD
Outcome results
None listed