Post Operative Pulmonary Complications, Robotic Surgery
Conditions
Keywords
Lung protective ventilation, Electric Impedance Tomography (EIT)
Brief summary
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.
Detailed description
The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.
Interventions
DEVICELow Intensity Mechanical Ventilation
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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure
Exclusion criteria
* Known pregnancy * Pre-existing intubation or tracheostomy * Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery * Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔEELV 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). | Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative oxygenation | 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 | Intraoperative peripheral pulsed oxygen saturation (SpO2) |
| Postoperative oxygenation | Postoperative Day 0: after PACU admission and 60min after PACU admission | Postoperative peripheral pulsed oxygen saturation (SpO2) |
| Intervention deliverability | From intubation to extubation at Day 0 | 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. |
| EELV | 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 | End-expiratory lung volume measured by Electrical Impedance Tomography in mL |
| COV | 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 | Center of ventilation measured by Electrical Impedance Tomography in percentage |
| RVDI | 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 | Regional ventilation delay inhomogeneity measured by Electrical Impedance Tomography (unitless) |
| GI | 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 | Global inhomogeneity index measured by Electrical Impedance Tomography (unitless) |
| Dorsal ROI | 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 | Maximum dorsal ratio of impedance measured by Electrical Impedance Tomography (unitless) |
| EEPL | Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation | End-expiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O) |
| EIPL | Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation | End-inspiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O) |
| Relationship between body mass index with optimal PEEP | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery | Correlation between BMI (kg/m²) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery. |
| Relationship of the degree of Trendelenburg inclination with optimal PEEP | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery | 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. |
| Proportion of patients with postoperative pulmonary complications at day 7 | This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery | Re-intubation, hypoxemia requiring oxygen therapy, pleural effusion, pneumonia, atelectasis or emergency non-invasive ventilation |
| Relationship of the pneumoperitoneum (insufflation) with optimal PEEP | Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery | 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. |
| Recruitment rate | Day 0 | Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached. |
Countries
United States
Outcome results
None listed