Morbid obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Adult patients with morbid obesity (BMI = 40 kg/m2 or BMI = 35 kg/m2 with comorbidities) scheduled for laparoscopic sleeve gastrectomy will be considered for the study. Patients will be classified as
Sponsors
University Medical Hospital of Padova
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. Morbid obesity (BMI = 40 kg/m2 or BMI = 35 kg/m2 with comorbidities) 3. Laparoscopic sleeve gastrectomy surgery
Exclusion criteria
Exclusion criteria: 1. Severe acute and/or chronic respiratory disease (e.g., asthma, COPD, severe restrictive disease) 2. Severe acute and/or chronic heart disease (e.g., acute or recent myocardial infarction, inducible ischemia, heart failure) 3. End-stage liver and kidney disease 4. Intolerance or allergy or contraindications to the drugs used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of different positive end-expiratory pressure (PEEP) setting regimens on intra-operative oxygenation measured using the PaO2/FiO2 ratio of arterial oxygen partial pressure [PaO2 in mmHg] to fractional inspired oxygen [FiO2 expressed as a fraction, not a percentage]. Parameters are monitored in a standard manner for general anesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary respiratory and cardiovascular variables are measured during the intraoperative time points: pre-peritoneum, during pneumoperitoneum, and after pneumoperitoneum. Parameters are monitored in a standard manner for general anesthesia: 1. Respiratory variables: Peak Inspiratory Pressure (cmH2O), Plateau Pressure (cmH2O), Positive End-Expiratory Pressure (PEEP) (cmH2O), Elastance (cmH2O/l), Compliance (ml/cmH2O), Inspiratory Flow (L/min), Respiratory Rate (breaths/min), Driving Pressure (cmH2O), Mechanical Power, Arterial Oxygen Saturation measured by Pulse Oximetry (SpO2) (%), Arterial Partial Pressure of Oxygen (PaO2) (mmHg), Arterial Partial Pressure of Carbon Dioxide (PaCO2) (mmHg), Arterial pH 2. Cardiovascular variables: Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Heart Rate (bpm) The following secondary post-anesthesia phase and ward discharge variables are measured at the following postoperative time points: 0, 15, 30, 60, 90, and 120 minutes after tracheal extubation, and 6, 24, 48, and 72 hours after surgery: 1. Pain intensity measured using a Numeric Rating Scale (NRS 0-10) 2. Intensity of nausea and/or vomiting measured using the NRS 0-10 3. Postoperative pulmonary complications (POPCs) | — |
Countries
Italy
Contacts
Public ContactMichele Carron
Outcome results
None listed