## Protocol Section
### Identification Module
**NCT ID:** NCT06430606

**Brief Title:** Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

**Official Title:** How Do Novel Oxygenation Indices Change With Trendelenburg Position in Robot-Assisted Laparoscopic Surgeries?

#### Organization Study ID Info
**ID:** 2024-05-
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Başakşehir Çam & Sakura City Hospital

#### Responsible Party

**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital

**Investigator Full Name:** Furkan Tontu

**Investigator Title:** Doctor of Anesthesiology and Reanimation

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Ventilator-Induced Lung Injury

**Keywords:**

- trendelenburg

- robot-assisted laparoscopic surgery

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 42

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Tint Time

- Procedure: T0 Time

- Procedure: T1

**Label:** Patients undergoing robotic-assisted laparoscopic surgery

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients undergoing robotic-assisted laparoscopic surgery

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

**Name:** Tint Time

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Patients undergoing robotic-assisted laparoscopic surgery

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

**Name:** T0 Time

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Patients undergoing robotic-assisted laparoscopic surgery

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

**Name:** T1

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum OSI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** 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.

**Measure:** Oxygenation indices

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

#### Secondary Outcomes

**Description:** Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum

**Measure:** Mechanical ventilator parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in compliance (mL/cmH2O) with Trendelenburg position and pneumoperitoneum

**Measure:** Mechanical ventilator parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in peak pressure (cmH2O) with Trendelenburg position and pneumoperitoneum

**Measure:** Mechanical ventilator parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the pH with Trendelenburg position and pneumoperitoneum

**Measure:** Arterial blood gas parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the base excess(mmol/lt) with Trendelenburg position and pneumoperitoneum

**Measure:** Arterial blood gas parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the partial oxgyen(mmHg) with Trendelenburg position and pneumoperitoneum

**Measure:** Arterial blood gas parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the partial carbon dioxide(mmHg) with Trendelenburg position and pneumoperitoneum

**Measure:** Arterial blood gas parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the lactate(mmol/lt) with Trendelenburg position and pneumoperitoneum

**Measure:** Arterial blood gas parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the heart rate with Trendelenburg position and pneumoperitoneum

**Measure:** Hemodynamic parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

**Description:** Change in the mean arterial blood pressure with Trendelenburg position and pneumoperitoneum

**Measure:** Hemodynamic parameters

**Time Frame:** during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Istanbul

**Country:** Turkey

**Facility:** Basaksehir Cam Sakura City Hospital

### IPD Sharing Statement Module

**Description:** Not decided yet

**IPD Sharing:** UNDECIDED

### References Module

#### References

**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. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.

**PMID:** 24283226

**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.

**PMID:** 20167583

**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.

**PMID:** 30139899

**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.

**PMID:** 25978326

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

**PMID:** 30201797

**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.

**PMID:** 37695139

**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 Jan 5:8850666231223498. doi: 10.1177/08850666231223498. Online ahead of print.

**PMID:** 38179691

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000013898

- Term: Thoracic Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28143

- Name: Lung Injury

- Relevance: HIGH

- As Found: Lung Injury

- ID: M28152

- Name: Ventilator-Induced Lung Injury

- Relevance: HIGH

- As Found: Ventilator-Induced Lung Injury

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16657

- Name: Thoracic Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000055370

- Term: Lung Injury

- ID: D000055397

- Term: Ventilator-Induced Lung Injury

### Misc Info Module

- Version Holder: 2024-05-31
