Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries
- Conditions
- Ventilator-Induced Lung Injury
- Interventions
- Procedure: Tint TimeProcedure: T0 TimeProcedure: T1
- Registration Number
- NCT06430606
- Lead Sponsor
- Başakşehir Çam & Sakura City Hospital
- Brief Summary
In this study, changes in new oxygenation indices investigated by Asar et al. will be compared with conventional oxygenation and saturation indices in patients undergoing robot-assisted laparoscopic surgery due to pneumoperitoneum and Trendelenburg position.
- Detailed Description
During the intraoperative period, optimal oxygenation should be achieved while avoiding the harmful effects of hypoxia and hyperoxia in patients. The PaO2/FiO2 and SpO2/FiO2 ratios have been traditionally used to assess this condition. Subsequently, oxygenation indices incorporating mean airway pressure have been developed, such as the oxygenation index (OI = (FiO2 × Pmean) / PaO2) and oxygenation saturation index (OSI = (FiO2 × Pmean) / SpO2). More recently, Asar et al. have defined 8 novel oxygenation indices using mean power (MP) and driving pressure (DP) instead of Pmean (OSI-MPtot, OI-MPtot, OSI-ΔPinsp, OI-ΔPinsp, OSI-MPdyn, OI-MPdyn, PaO2/(FiO2xPEEP), and SpO2/FiO2xPEEP). They compared the predictive power of these new indices for intensive care unit (ICU) mortality in COVID-ARDS (C-ARDS) patients with conventional oxygenation indices (PaO2/FiO2, SpO2/FiO2, OI, OSI). OI-ΔPinsp, OSI-ΔPinsp, and OSI-MPdyn indices were found to have the highest predictive power for ICU mortality. However, there is currently no study investigating the changes of these new indices during the intraoperative period.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
- ASA (American Society of Anesthesiologists) class I-III
- Age between 18-75 years
- Signed informed consent form
- Diagnosis of COPD (Chronic Obstructive Pulmonary Disease) and asthma
- History of thoracic surgery
- Body mass index (BMI) > 35
- Development of hemodynamic instability or desaturation (SpO2 < 92) during the operation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing robotic-assisted laparoscopic surgery Tint Time The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery. Patients undergoing robotic-assisted laparoscopic surgery T0 Time The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery. Patients undergoing robotic-assisted laparoscopic surgery T1 The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery.
- Primary Outcome Measures
Name Time Method Oxygenation indices during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI (oxygenation saturation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.
- Secondary Outcome Measures
Name Time Method Arterial blood gas parameters during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) Change in the lactate(mmol/lt) with Trendelenburg position and pneumoperitoneum
Mechanical ventilator parameters during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) Change in peak pressure (cmH2O) with Trendelenburg position and pneumoperitoneum
Hemodynamic parameters during the surgery and immediately after the surgery (approximately 3 hours to 6 hours) Change in the mean arterial blood pressure with Trendelenburg position and pneumoperitoneum
Trial Locations
- Locations (1)
Basaksehir Cam Sakura City Hospital
🇹🇷Istanbul, Turkey