Clinical trial NCT06430606: Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries
Official title: How Do Novel Oxygenation Indices Change with Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Induced Lung Injury
Keywords: trendelenburg
robot-assisted laparoscopic surgery
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Oxygenation indices
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Secondary outcomes:
measure: Mechanical ventilator parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Mechanical ventilator parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Mechanical ventilator parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Arterial blood gas parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Arterial blood gas parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Arterial blood gas parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Arterial blood gas parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Arterial blood gas parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Hemodynamic parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
measure: Hemodynamic parameters
timeFrame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basaksehir Cam Sakura City Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.
citation: 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.
citation: 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.