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NCT Number: NCT06430606

Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

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.

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Key information

Conditions

Ventilator-Induced Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Basaksehir Cam Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tint Time

Procedure

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

T0 Time

Procedure

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

T1

Procedure

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

Primary outcomes

  1. Oxygenation indices

    Time frame: during 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.

  2. Oxygenation indices

    Time frame: during 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 on OI-MPtot in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  3. Oxygenation indices

    Time frame: during 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 on OSI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  4. Oxygenation indices

    Time frame: during 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 on OI-ΔPinsp in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  5. Oxygenation indices

    Time frame: during 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 on OSI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  6. Oxygenation indices

    Time frame: during 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 on OI-MPdyn in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  7. Oxygenation indices

    Time frame: during 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 on PaO2/(FiO2xPEEP) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  8. Oxygenation indices

    Time frame: during 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 on SpO2/FiO2xPEEP in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  9. Oxygenation indices

    Time frame: during 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 on SpO2/FiO2 in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  10. Oxygenation indices

    Time frame: during 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 on OI (oxygenation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

  11. Oxygenation indices

    Time frame: during 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 on OSI (oxygenation saturation index) in ASA I-III patients undergoing robot-assisted laparoscopic surgery.

Secondary outcomes

  1. Mechanical ventilator parameters

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

    Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum

  2. Mechanical ventilator parameters

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

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

  3. Mechanical ventilator parameters

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

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

  4. Arterial blood gas parameters

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

    Change in the pH with Trendelenburg position and pneumoperitoneum

  5. Arterial blood gas parameters

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

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

  6. Arterial blood gas parameters

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

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

  7. Arterial blood gas parameters

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

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

  8. Arterial blood gas parameters

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

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

  9. Hemodynamic parameters

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

    Change in the heart rate with Trendelenburg position and pneumoperitoneum

  10. Hemodynamic parameters

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

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

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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