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One-lung VentilationNCT06376123

Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation

An observational study of One-lung Ventilation, run by Bezmialem Vakif University 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
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Trial summary

The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
One-lung Ventilation
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2024to 1 Nov 2024
How long will I take part?
2 Days
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study includes patients with pulmonary diseases, indicated for surgery. Among them are pulmonectomy, segmentectomy, lobectomy or wedge resections. All these types of surgery require one-lung (non-operating lung) ventilation. The patients should be electively operated, aged more that 18 years and must have no other pulmonary conditions (like fibrosis, pneumonia, lung oedema or interstitial lung disease) that could interfere with Alveolo-arterial gradient calculations.

Who may be able to join

  • Patients scheduled for elective VATS surgery.
  • Age over 18 years.
  • ASA 1-4 patients.

Who cannot join

  • Patient refusal.
  • Age below 18 years.
  • Conditions that may impair oxygen diffusion: pulmonary oedema, fibrosis, interstitial lung disease, pneumonia.
  • Emergency surgery.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bezmialem Vakif University Dragos Hospital

    Istanbul, Maltepe, 34844

Other trials in Turkey (Türkiye)

About this study

The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly.

Read the detailed description

The shunt that occurs during one lung ventilation varies for each patient and depends on many parameters. In this study, our aim was to predict the level of shunting during anaesthesia using readily available preoperative data. It is important to predict the hypoxia that will develop due to the shunt and to plan the methods that can be applied to reduce the shunt in terms of patient safety. One of the most reliable data reflecting the shunt level is the gradient of alvelo- arterial oxygen concentration. The calculation of alveolo-arterial oxygen gradient (A-a O2 gradient) is based on easily accessible parameters (pO2, pCO2, FiO2, age). The secondary aim of the study is to follow how the A-a O2 gradient (oxygen difference between alveolar and arterial blood) changes over time during surgery.

Demographic data, planned operation, comorbidities, side of surgery, ASA score, preoperative haemoglobin level, FEV1 (forced expiratory volume in 1 minute), FEV1/FVC (forced expiratory volume in 1 minute/forced vital capacity) ratio and EF (ejection fraction) will be recorded before surgery.FEV1, FEV1/FVC ratio values will be measured by spirometry test. Spirometry is a preoperative test routinely performed in all patients undergoing one lung ventilation. EF will be measured by preoperative echocadiography, which is also performed during the preoperative preparation of all patients scheduled for lung surgery. Patients undergoing VATS (video-assisted thoracoscopy) surgery with planned lung resection, lobectomy, pulmonectomy, segmentectomy etc. will be included in the study and all will be operated in the lateral decubitus position.

Once the patient is on the operating table, routine haemodynamic monitoring (heart rate, non-invasive blood pressure and blood oxygen saturation) will be performed.

The patient will then have an arterial cannula inserted for invasive arterial monitoring. It is a routine practice in major surgeries for blood gas monitoring, haemorrhage monitoring and monitoring of sudden blood pressure fluctuations. After insertion of the arterial cannula, blood gas will be taken in room air and arterial pO2 (partial oxygen pressure), arterial pCO2 (partial carbon dioxide pressure) and arterial SpO2 (oxygen saturation) will be recorded. At the same time, a venous blood sample (from any vein in the upper limb) will be taken in room air and vSpO2 (venous blood oxygen saturation) will be recorded. The difference between SpO2 of arterial and venous blood is determined as Delta-SpO2 and is a specific parameter of this study.

All patients will undergo general anaesthesia and orotracheal intubation with a double lumen tube.

For anaesthesia induction, 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be administered .After adequate mask ventilation and complete muscle relaxation, a double lumen intubation tube will be placed into the trachea by direct laryngoscopy. After the position of the tube and whether it is in the correct bronchus is supported by bronchoscopy, the patient will be connected to the mechanical ventilator and lateral decubitus (provided that the side to be operated on remains on top) will be given. Ventilator parameters will be selected the same for all patients. During two-lung ventilation, tidal volume 8 ml/kg, respiratory rate 12, peep 5, and FiO2 (fraction of inspired oxygen) = 60%. During one-lung ventilation, tidal volume will be set to 6 ml/min, respiratory rate 15, peep 5, and FiO2 = 70%. All patients will be ventilated in volume control mode.

At this stage, EtCO2 (end-tidal carbon dioxide) will be measured separately in both lungs. For this, first the airway from the lower lung will be clamped and the EtCO2 value will be recorded (dEtCO2 - dependent lung EtCO2). Then, vice versa, the airway from the lower lung will be clamped and the EtCO2 value obtained (ndEtCO2 - non-dependent lung EtCO2) will be recorded. The difference between these two values, D-EtCO2 (delta - end-tidal carbon dioxide) will be added to the data.

After these steps, one-lung ventilation will be started and the first A-a oxygen gradient will be recorded 30 minutes after initiation of OLV. The consequent calculations of OLV will be made every 30 minutes until the end of the surgery. The consequent measurements are necessary for estimation the A-a gradient change over time.

Keywords
One lung ventilation, Alveolo-arterial gradient, Nomograms

What participants receive

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

Study groups in NCT06376123
Study groupRoleWhat they receive
Video assisted thoracoscopic surgery patientsPatients, assigned for elective lung surgery, older than 18 years and requiring one-lung ventilation.

What is being measured

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

  1. Alveolo-arterial gradient

    The gradient of oxygen concentration between alveoli and arterial blood, achieved after patient switch from double lung to one lung lung ventilation. Is calculated automatically, based on oxygen tension in arterial and venous blood, which measured by blood gas analysis.

    Measured: 30 mins after intubation

Secondary outcomes (1)
  1. Alveolo-arterial gradient change

    The gradient of oxygen concentration between alveoli and arterial blood, achieved after patient switch from double lung to one lung lung ventilation. It is measured be blod gas analysis. The secondary outcome involves the changes of the first outcome throughout the surgery and is measured every 30 minutes

    Measured: After switching to one lung ventilation

Timeline

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

  1. First posted19 Apr 2024
  2. Study start1 Jun 2024
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 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 only
Time perspective
Prospective
Enrolment
40 participants (actual)
Target duration
2 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376123
Sponsor's protocol ID
Nkangarli001
Status last verified
Dec 2025
First submitted
17 Apr 2024
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Parab SY, Chatterjee A, Saxena RS. The utility of gradient of end-tidal carbon dioxide between two lungs in lateral decubitus position in predicting a drop in oxygenation during one-lung ventilation in elective thoracic surgery- A prospective observational study. Indian J Anaesth. 2021 Oct;65(10):744-749. doi: 10.4103/ija.ija_591_21. Epub 2021 Oct 29.

    PubMed 34898701
  • Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.

    PubMed 19417615
  • Alday E, Nieves JM, Planas A. Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):417-422. doi: 10.1053/j.jvca.2019.06.035. Epub 2019 Jun 28.

    PubMed 31362907

Questions about this trial

What is this clinical trial studying?

An observational study of One-lung Ventilation, run by Bezmialem Vakif University 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 24 Dec 2025. 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?

Alveolo-arterial gradient (time frame: 30 mins after intubation). 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 NCT06376123, which also lists 3 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 24 Dec 2025.

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