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Completed

NCT Number: NCT07445698

Oxygen Reserve Index in Laparoscopic Colorectal Surgery

During laparoscopic procedures, certain physiological changes occur due to the creation of pneumoperitoneum. One such change is the reduction in portal venous blood flow, which can lead to decreased liver perfusion and acute liver cell injury. Additionally, due to an increased alveolar-arterial oxygen pressure gradient, postoperative atelectasis may occur, leading to hypoxia.

In other words, the increased intra-abdominal pressure during laparoscopic surgery-along with the effects of patient positioning and mechanical ventilation used during anesthesia-can worsen low blood oxygen levels, especially in patients with already reduced lung compliance and higher metabolic demands. This makes close monitoring of oxygenation crucial.

The Oxygen Reserve Index (ORI) is a relatively new tool that can help monitor both high oxygen levels (hyperoxemia) and drops in oxygen (desaturation) before they become clinically apparent. Studies have shown that ORI values range from 0 to 1, with an ORI of 0 typically corresponding to a PaO₂ level between 80-125 mmHg. A downward trend in ORI can act as an early warning sign of hypoxemia, giving clinicians a chance to act before it's too late.

Many studies have highlighted the potential harms of using high oxygen concentrations during surgery. For example, while most hospitals still give patients 100% oxygen before anesthesia (a process called preoxygenation), recent evidence suggests this might increase the risk of atelectasis. Therefore, using 80% or less oxygen is now being recommended in many settings. High oxygen levels have also been linked to increased oxidative stress in the body.

In this study, we aim to investigate whether monitoring ORI during extubation can help us detect and prevent both hyperoxemia and hypoxemia-situations that standard pulse oximetry often misses. We plan to compare two groups of patients: one receiving conventional 100% oxygen during extubation, and another receiving 80% oxygen. By monitoring ORI values in both groups, we hope to better understand how different oxygen levels affect patient safety and outcomes.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kartal Dr. Lütfi Kırdar Eğitim ve Araştırma hastanesi

Istanbul, Kartal, 34865, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-75
  • ASA: I-II
  • Scheduled for elective laparoscopic surgery
  • BMI <35

Exclusion criteria

  • Patients undergoing emergency surgery due to trauma
  • Patients with ASA physical status classification III or IV
  • Patients requiring intensive care unit admission
  • Patients with active, clinically symptomatic anemia
  • Patients with heart failure
  • Patients with known allergy to the sensor material to be used
  • Patients with difficult mask ventilation or difficult intubation
  • Patients with a platelet count below 30,000/mm³
  • Patients with a history of gastrointestinal bleeding within the past 6 months
  • Patients with a history of bleeding diathesis or increased risk of intracerebral hemorrhage
  • Patients with oliguria and/or those who required dialysis or underwent dialysis within one month prior to surgery
  • Patients with a known hypersensitivity reaction to any anesthetic or analgesic drug used in the study
  • Patients who do not wish to participate in the study

Treatment and study plan

Oxygen Administration During Extubation

Behavioral

This intervention involves the administration of oxygen during tracheal extubation in patients undergoing laparoscopic surgery. Two different oxygen concentrations are compared: the control group receives 100% oxygen, while the study group receives 80% oxygen during the extubation phase. All patients are monitored using the Oxygen Reserve Index (ORI) to assess oxygenation status continuously. The goal is to evaluate the effect of oxygen concentration on peri-extubation hyperoxia and hypoxia, as detected by ORI values. The intervention is non-invasive and administered via standard anesthesia breathing systems.

Primary outcomes

  1. Oxygen Reserve Index (ORI ) at 5 minutes post-extubation

    Time frame: ORI will be recorded at 5 minutes post-extubation using a Masimo Radical-7 pulse co-oximeter to assess peri-extubation oxygen reserve.

    Oxygen Reserve Index (ORI) will be continuously monitored using a Masimo Radical-7 pulse co-oximeter from the time of extubation until 60 minutes post-extubation. The ORI value recorded at the 5th minute after tracheal extubation will be used for primary outcome analysis.

Secondary outcomes

  1. Peripheral Oxygen Saturation (SpO₂, %) trends during and after extubation

    Time frame: Continuous monitoring during and up to 60 minutes after tracheal extubation

  2. Arterial oxygen partial pressure (PaO₂, mmHg) at 5 minutes post-extubation

    Time frame: 5 minutes after tracheal extubation

    Arterial blood gas analysis will be performed to measure PaO₂ and evaluate early postoperative oxygenation status following extubation.

  3. Oxygen Reserve Index (ORI) at 60 minutes post-extubation

    Time frame: 60 minutes after tracheal extubation

    ORI will be continuously monitored from extubation until 60 minutes post-extubation using a Masimo Radical-7 device. The ORI value at the 60th minute will be recorded to assess sustained postoperative oxygen reserve.

  4. Arterial oxygen partial pressure (PaO₂, mmHg) at 60 minutes post-extubation

    Time frame: 60 minutes after tracheal extubation

    Arterial blood gas analysis will be used to measure PaO₂ at 60 minutes post-extubation to evaluate sustained oxygenation differences between study groups.

  5. Heart rate during the first postoperative hour

    Time frame: From extubation until 60 minutes post-extubation

    Heart rate will be continuously monitored to evaluate hemodynamic stability during emergence and the early postoperative period.

  6. Mean arterial pressure (mmHg) during the first postoperative hour

    Time frame: From extubation until 60 minutes post-extubation

    Mean arterial pressure will be continuously monitored to assess hemodynamic changes during emergence and the early postoperative period.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of 100% and 80% Oxygen Use During Extubation on Oxygen Reserve Index in Laparoscopic Colorectal Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

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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