Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

How Do Novel Oxygenation Indices Change with Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries?

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-Induced Lung Injury
• Intervention / Treatment: Procedure: Tint Time; Procedure: T0 Time; Procedure: T1

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Basaksehir Cam Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study Population The study will include 42 volunteer patients, aged over 18, classified under the American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk groups, who are scheduled to undergo robot-assisted laparoscopic surgery at the Health Sciences University Basaksehir Cam and Sakura City Hospital operating room.

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) class I-III
• Age between 18-75 years
• Signed informed consent form

Exclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing robotic-assisted laparoscopic surgery; The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery.

Procedure: Tint Time; Arterial blood gas was obtained immediately after intubation(Tint) in supine position. Ventilator parameters and hemodynamic parameters were recorded.; Procedure: T0 Time; Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.; Procedure: T1; Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum OSI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on PaO2/(FiO2xPEEP) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2xPEEP in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on SpO2/FiO2 in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI (oxygenation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Oxygenation indices	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.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilator parameters	Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Mechanical ventilator parameters	Change in compliance (mL/cmH2O) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Mechanical ventilator parameters	Change in peak pressure (cmH2O) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Arterial blood gas parameters	Change in the pH with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Arterial blood gas parameters	Change in the base excess(mmol/lt) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Arterial blood gas parameters	Change in the partial oxgyen(mmHg) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Arterial blood gas parameters	Change in the partial carbon dioxide(mmHg) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Arterial blood gas parameters	Change in the lactate(mmol/lt) with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Hemodynamic parameters	Change in the heart rate with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Hemodynamic parameters	Change in the mean arterial blood pressure with Trendelenburg position and pneumoperitoneum	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital

Publications and helpful links

General Publications

• Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
• Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
• Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.
• Queiroz VNF, da Costa LGV, Barbosa RP, Takaoka F, De Baerdemaeker L, Cesar DS, D'Orto UC, Galdi JR, Gottumukkala V, Cata JP, Hemmes SNT, Hollman MW, Kalmar A, Moura LAB, Mariano RM, Matot I, Mazzinari G, Mills GH, Posso IP, Teruya A, Vidal Melo MF, Sprung J, Weingarten TN, Treschan TA, Koopman S, Eidelman L, Chen LL, Lee JW, Arino Irujo JJ, Tena B, Groeben H, Pelosi P, de Abreu MG, Schultz MJ, Serpa Neto A; AVATaR and PROVE Network investigators. International multicenter observational study on assessment of ventilatory management during general anaesthesia for robotic surgery and its effects on postoperative pulmonary complication (AVATaR): study protocol and statistical analysis plan. BMJ Open. 2018 Aug 23;8(8):e021643. doi: 10.1136/bmjopen-2018-021643.
• O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.
• Tartler TM, Ahrens E, Munoz-Acuna R, Azizi BA, Chen G, Suleiman A, Wachtendorf LJ, Costa ELV, Talmor DS, Amato MBP, Baedorf-Kassis EN, Schaefer MS. High Mechanical Power and Driving Pressures are Associated With Postoperative Respiratory Failure Independent From Patients' Respiratory System Mechanics. Crit Care Med. 2024 Jan 1;52(1):68-79. doi: 10.1097/CCM.0000000000006038. Epub 2023 Sep 11.
• Asar S, Rahim F, Rahimi P, Acicbe O, Tontu F, Cukurova Z. Novel Oxygenation and Saturation Indices for Mortality Prediction in COVID-19 ARDS Patients: The Impact of Driving Pressure and Mechanical Power. J Intensive Care Med. 2024 Jun;39(6):595-608. doi: 10.1177/08850666231223498. Epub 2024 Jan 5.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: trendelenburg; robot-assisted laparoscopic surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 2024-05-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No