Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

NCT06430606 | Completed

• 1 other identifier: 2024-05-
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Induced Lung Injury

Keywords

trendelenburg; robot-assisted laparoscopic surgery

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (10)

• Mechanical ventilator parameters

  during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

• Mechanical ventilator parameters

  during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

• Mechanical ventilator parameters

  during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

• Arterial blood gas parameters

  during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

• Arterial blood gas parameters

  during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

Study Arms (1)

Patients undergoing robotic-assisted laparoscopic surgery

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

Procedure: Tint Time; Procedure: T0 Time; Procedure: T1

Interventions

Tint Time PROCEDURE

Arterial blood gas was obtained immediately after intubation(Tint) in supine position. Ventilator parameters and hemodynamic parameters were recorded.

Patients undergoing robotic-assisted laparoscopic surgery

T0 Time PROCEDURE

Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.

Patients undergoing robotic-assisted laparoscopic surgery

T1 PROCEDURE

Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.

Patients undergoing robotic-assisted laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 20167583 BACKGROUND

• 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.

  PMID: 30139899 BACKGROUND

• 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.

  PMID: 24283226 BACKGROUND

• 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.

  PMID: 25978326 BACKGROUND

• O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030.

  PMID: 30201797 BACKGROUND

• 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.

  PMID: 37695139 BACKGROUND

• 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.

  PMID: 38179691 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 28, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

TU (1)