Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

Ventilator-Induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06430606
• Other study ID #: 2024-05-
• Status: Active, not recruiting
• Start date: May 1, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: May 2024
• Source: Basaksehir Çam & Sakura City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: July 15, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Induced Lung Injury

Intervention

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

Locations

Country	Name	City	State
Turkey	Basaksehir Cam Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Çam & Sakura City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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 Anaest — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OSI-?Pinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Primary	Oxygenation indices	This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum on OI-?Pinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.	during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)