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Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06430606
Enrollment
56
Registered
2024-05-28
Start date
2024-05-01
Completion date
2024-08-30
Last updated
2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-Induced Lung Injury

Keywords

trendelenburg, robot-assisted laparoscopic surgery

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.

Interventions

PROCEDURET1

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

PROCEDURETint Time

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

PROCEDURET0 Time

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

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenation indicesduring the surgery and immediately after the surgery (approximately 3 hours to 6 hours)This study aims to investigate the effects of Trendelenburg position and pneumoperitoneum OSI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

Secondary

MeasureTime frameDescription
Mechanical ventilator parametersduring the surgery and immediately after the surgery (approximately 3 hours to 6 hours)Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum
Arterial blood gas parametersduring the surgery and immediately after the surgery (approximately 3 hours to 6 hours)Change in the pH with Trendelenburg position and pneumoperitoneum
Hemodynamic parametersduring the surgery and immediately after the surgery (approximately 3 hours to 6 hours)Change in the heart rate with Trendelenburg position and pneumoperitoneum

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026