AzTrials
AzTrials

Ventilator-Induced Lung InjuryNCT06430606

Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

An observational study of Ventilator-Induced Lung Injury, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ventilator-Induced Lung Injury
What is being tested?
Tint Time, T0 Time and T1
Type of treatment
Surgery or procedure
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2024to 30 Aug 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • 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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Basaksehir Cam Sakura City Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: How Do Novel Oxygenation Indices Change With Trendelenburg Position 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.

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.

Being tested
Tint Time, T0 Time, T1
Keywords
trendelenburg, robot-assisted laparoscopic surgery
Medical subject headings
Ventilator-Induced Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tint TimeProcedure or surgery

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

  • T0 TimeProcedure or surgery

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

  • T1Procedure or surgery

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

Study groups in NCT06430606
Study groupRoleWhat they receive
Patients undergoing robotic-assisted laparoscopic surgeryThe patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery.
Receives: Procedure: Tint Time; Procedure: T0 Time; Procedure: T1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (10)

  1. Mechanical ventilator parameters

    Change in PEEP (cmH2O) with Trendelenburg position and pneumoperitoneum

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start1 May 2024
  3. Primary completion1 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
56 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06430606
Sponsor's protocol ID
2024-05-
Status last verified
Sep 2024
First submitted
15 May 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Not decided yet

Publications

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilator-Induced Lung Injury, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygenation indices (time frame: during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06430606, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in