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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure: 1. Recruitment maneuver 2. Tidal volume set to 8 ml/kg predicted body weight (PBW) and stepwise adjustment to achieve a driving pressure (Plateau pressure - PEEP) \< 13 cmH2O with a minimum tidal volume of 5ml/kg PBW 3. Respiratory rate adjustment to maintain a target end-tidal carbon dioxide concentration (etCO₂) between 45 and 55 mmHg. 4. Reassessment and adaptation after Trendelenburg positioning and pneumoperitoneum. 5. Re-adjustment of Tidal Volume and PEEP ventilator settings to (2.) after exsufflation and return to the supine position. FiO₂ set to 70% during the washout phase of the inhalational anesthetic until extubation.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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.
Time frame: 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).
Proportion of patients with postoperative pulmonary complications at day 7
Re-intubation, emergency non-invasive ventilation or pneumonia
Time frame: This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery
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).
Time frame: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation
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, %).
Time frame: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation
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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, %).
Time frame: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation
Change in estimated pulmonary artery systolic pressure (PASP, mmHg) from pre-intubation baseline to first post-extubation echocardiogram
Pulmonary hemodynamics will be assessed by transthoracic echocardiography using estimated pulmonary artery systolic pressure (PASP, measured in millimeters of mercury). PASP 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 PASP (post-extubation minus baseline, mmHg)
Time frame: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation
Recruitment rate
Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached.
Time frame: 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.
Time frame: From intubation to extubation at Day 0
EELV
End-expiratory lung volume measured by Electrical Impedance Tomography in mL
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery
Intraoperative oxygenation
Intraoperative peripheral pulsed oxygen saturation (SpO2)
Time frame: 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)
Time frame: Postoperative Day 0: after PACU admission and 60min after PACU admission