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The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.
The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | A guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis. | |
| Intervention | Experimental | A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Mechanical Ventilation | Device | A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure:
|
| Measure | Description | Time Frame |
|---|---|---|
| ΔEELV between baseline and after extubation before leaving the operating room. | Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room. | Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with postoperative pulmonary complications at day 7 | Re-intubation, hypoxemia requiring oxygen therapy, pleural effusion, pneumonia, atelectasis or emergency non-invasive ventilation | This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29793604 | Result | Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13. | |
| 25018668 | Result | Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186/1471-2253-14-51. eCollection 2014. |
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|
| Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram |
Right-ventricular systolic function will be assessed by transthoracic echocardiography using tricuspid annular plane systolic excursion (TAPSE, measured in millimeters). TAPSE will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The primary outcome for this measure will be the change in TAPSE (post-extubation minus baseline, mm). |
| Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration |
| Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram | Right-ventricular systolic function will be assessed by transthoracic echocardiography using right-ventricular fractional area change (RV-FAC, expressed as percentage). RV-FAC will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The outcome for this measure will be the change in RV-FAC (post-extubation minus baseline, %). | Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration |
| Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram | Left ventricular systolic function will be assessed by transthoracic echocardiography using left ventricular ejection fraction (LVEF, expressed as percentage). LVEF will be recorded at pre-intubation baseline and at the first postoperative transthoracic echocardiographic examination after extubation. The outcome for this measure will be the change in LVEF (post-extubation minus baseline, %). | Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration |
| Recruitment rate | Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached. | Day 0 |
| Intervention deliverability | proportion of patients in the intervention arm in whom the full bundle of protective low-intensity ventilation strategies is delivered as planned across all predefined intraoperative phases. | From intubation to extubation at Day 0 |
| EELV | End-expiratory lung volume measured by Electrical Impedance Tomography in mL | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission |
| COV | Center of ventilation measured by Electrical Impedance Tomography in percentage | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission |
| RVDI | Regional ventilation delay inhomogeneity measured by Electrical Impedance Tomography (unitless) | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission |
| GI | Global inhomogeneity index measured by Electrical Impedance Tomography (unitless) | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission |
| Dorsal ROI | Maximum dorsal ratio of impedance measured by Electrical Impedance Tomography (unitless) | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission |
| EEPL | End-expiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O) | Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation |
| EIPL | End-inspiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O) | Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation |
| Relationship between body mass index with optimal PEEP | Correlation between BMI (kg/m²) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery. | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery |
| Relationship of the degree of Trendelenburg inclination with optimal PEEP | Correlation between the degree of Trendelenburg inclination (in degree) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery. | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery |
| Relationship of the pneumoperitoneum (insufflation) with optimal PEEP | Correlation between the pneumoperitoneum (insufflation in cmH2O) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery. | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery |
| Intraoperative oxygenation | Intraoperative peripheral pulsed oxygen saturation (SpO2) | Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation |
| Postoperative oxygenation | Postoperative peripheral pulsed oxygen saturation (SpO2) | Postoperative Day 0: after PACU admission and 60min after PACU admission |