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CompletedNCT06430606Updated Sep 5, 2024

Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

An observational study in Ventilator-Induced Lung Injury, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-05.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator-Induced Lung Injury

Keywords

  • trendelenburg
  • robot-assisted laparoscopic surgery
03

In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's enrollment of 56 is below the median of 70 across 136 observational studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 105 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
56 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • 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.

  • ProcedureT1

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

Secondary outcomes

  1. Mechanical ventilator parameters

    Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum

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

  2. Mechanical ventilator parameters

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

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

  3. Mechanical ventilator parameters

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

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

  4. Arterial blood gas parameters

    Change in the pH with Trendelenburg position and pneumoperitoneum

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

  5. Arterial blood gas parameters

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

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

  6. Arterial blood gas parameters

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

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

  7. Arterial blood gas parameters

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

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

  8. Arterial blood gas parameters

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

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

  9. Hemodynamic parameters

    Change in the heart rate with Trendelenburg position and pneumoperitoneum

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

  10. Hemodynamic parameters

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

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

07

Study locations

1 site
  • Basaksehir Cam Sakura City Hospital
    Istanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 20167583 ↗
  • 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. PubMed 30139899 ↗
  • 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. PubMed 24283226 ↗
  • 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. PubMed 25978326 ↗
  • O'Gara B, Talmor D. Perioperative lung protective ventilation. BMJ. 2018 Sep 10;362:k3030. doi: 10.1136/bmj.k3030. PubMed 30201797 ↗
  • 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. PubMed 37695139 ↗
  • 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. PubMed 38179691 ↗

Individual participant data

Plan to share: Undecided — Not decided yet

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06430606
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Responsible party
Furkan Tontu (Doctor of Anesthesiology and Reanimation, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
May 28, 2024
Start date
May 1, 2024
Primary completion
Aug 1, 2024
Completion
Aug 30, 2024
Last update
Sep 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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