Novel Oxygenation Indices in Robot-Assisted Laparoscopic Surgeries

September 1, 2024 updated by: Furkan Tontu, Başakşehir Çam & Sakura City Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Başakşehir Çam Sakura City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients undergoing robotic-assisted laparoscopic surgery
The patients consist of ASA I-II or III group undergoing robotic-assisted laparoscopic surgery.
Procedure: Tint Time
Arterial blood gas was obtained immediately after intubation(Tint) in supine position. Ventilator parameters and hemodynamic parameters were recorded.
Procedure: T0 Time
Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.
Procedure: T1
Arterial blood gas was obtained immediately after pneumoperitoneum in trendelenburg position. Ventilator parameters and hemodynamic parameters were recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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.
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)
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
during the surgery and immediately after the surgery (approximately 3 hours to 6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-05-

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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