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Evaluation of Oxygen Administration Methods During One-Lung Ventilation in Patients Undergoing Lung Resection Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial examines different methods of oxygen delivery during Lung Resection Surgery. This type of surgery involves removing a portion of the lung and requires special breathing support during the procedure. The study uses Medical Oxygen, which is a compressed gas that patients breathe in through special equipment during surgery.

The research aims to find out how different ways of delivering oxygen to the non-operating side of the lung during surgery might affect recovery and complications afterward. The study will use three different techniques of giving oxygen to the lung that is not being operated on while the patient is under anesthesia. During the surgery, one lung is temporarily not used for breathing, which is called one-lung ventilation.

Patients who participate in this study will receive one of three different methods of oxygen delivery during their surgery. The medical team will monitor various aspects of recovery after surgery, including how well patients breathe, their overall recovery, and how long they need to stay in the hospital. The study will also look at certain substances in the blood and lung fluid that can show how the body responds to the surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical procedure

    You will undergo a lung resection surgery, which requires isolating one lung using a special tube (double-lumen tube).

    During the surgery, one lung will be ventilated while the other will receive oxygen through one of three different methods.

  2. Step 2

    Oxygen administration

    You will receive medical oxygen through inhalation during the procedure.

    The oxygen will be administered as a compressed gas at 200 bar pressure.

    The non-ventilated lung will receive oxygen using one of three specific techniques to be determined by the study protocol.

  3. Step 3

    Monitoring during surgery

    During the operation, medical staff will monitor:

    - How your body processes gases and maintains proper acid levels in the blood

    - How the oxygen administration affects the surgeon's ability to operate

    Blood samples and lung fluid samples will be collected to analyze inflammation markers.

  4. Step 4

    Post-surgery monitoring

    After the surgery, you will be monitored for any complications.

    The medical team will track:

    - Any complications that may develop

    - Time spent in special care units

    - Length of hospital stay

    - Need for readmission to special care units or hospital

  5. Step 5

    Study duration

    The study period runs from November 2024 to January 2027.

    Your participation will involve the surgery period and subsequent recovery monitoring.

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must be able to make legal decisions for themselves (legally competent)
  • Can be either male or female
  • Must be scheduled for lung resection surgery (an operation to remove part of the lung) that requires using a special breathing tube (double-lumen tube) to separate the lungs during surgery
  • Must voluntarily agree to participate in the study
  • Must be willing and able to sign the informed consent form (a document explaining the study details and patient rights)
  • Must not be part of any vulnerable population groups (such as prisoners or persons unable to give consent)

Who cannot join the trial?

15 criteria

  • Age under 18 or over 65 years
  • Pregnancy or breastfeeding
  • History of previous thoracic surgery (surgery involving the chest area)
  • Known severe lung disease (such as severe asthma or chronic obstructive pulmonary disease)
  • Cardiovascular diseases (serious heart conditions)
  • Inability to understand and sign informed consent
  • Pleural adhesions (abnormal tissue connections between the lung and chest wall)
  • Emergency surgery cases
  • Coagulation disorders (blood clotting problems)
  • Active infection
  • Body Mass Index (BMI) over 35 (severe obesity)
  • Neuromuscular diseases (conditions affecting nerves and muscles)
  • Participation in another clinical trial within the past 30 days
  • Known allergies to medications used in anesthesia
  • Immunodeficiency (weakened immune system)
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Investigated drugs

Oxygen therapy - This involves delivering continuous oxygen flow to the non-ventilated lung during surgery. Oxygen therapy helps maintain proper oxygenation of lung tissue when only one lung is being mechanically ventilated during chest surgery. Positive Airway Pressure - This therapy involves applying gentle air pressure to keep the airways open while delivering oxygen to the non-ventilated lung during surgery. It helps maintain better oxygen levels and prevents the collapse of air passages in the lung that is not being mechanically ventilated. Both therapies are used during one-lung ventilation, which is a special breathing technique used during lung surgery where one lung is temporarily not ventilated to allow surgeons better access to perform the operation.

What is already known about the treatment

Based on the provided clinical trial data, this study focuses on oxygen administration rather than specific medications. However, I can provide a description of medical oxygen as it's the primary substance being studied: Medical Oxygen - A medical gas administered through various respiratory devices during surgery and medical procedures, particularly during one-lung ventilation in lung resection surgery. It is classified as an essential medical gas that supports breathing and maintains adequate oxygen levels in the blood, with its primary mechanism of action being the direct oxygenation of blood through alveolar gas exchange in the lungs. Medical oxygen is typically administered through specialized medical equipment that can control flow rates and pressure, and it remains a fundamental component in modern surgical procedures and respiratory support. Note: The trial specifically examines different techniques of oxygen administration during lung surgery, but no other medications are explicitly mentioned in the source data.

Investigated diseases

  • Post-operative Pulmonary Complications

    A group of respiratory problems that can develop after surgery, particularly following lung resection procedures. These complications involve changes in lung function and can include temporary breathing difficulties, decreased oxygen levels, and accumulation of fluid in lung tissues. The condition typically develops within the first few days after surgery and may be influenced by factors such as the type of surgical procedure and pre-existing lung function.

  • Oxidative Stress in Lung Surgery

    A condition occurring during lung operations where there is an imbalance between oxidants and antioxidants in lung tissue. This process involves the production of reactive oxygen species that can affect lung cells during surgery. The condition develops when one lung is not ventilated during surgery, which can lead to inflammation and temporary changes in lung tissue.

  • Acid-Base Imbalance

    A condition where the body's pH levels become disrupted during and after lung surgery. This occurs when there are changes in the blood's oxygen and carbon dioxide levels due to one-lung ventilation. The body typically works to maintain proper pH balance through various compensatory mechanisms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517599-39-00Protocol codeECAOI-22Estimated enrolment177 patientsSponsorHospital General Universitario Gregorio Maranon

sourced from the EU Clinical Trials Register and site verification

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