Skip to main content
OpenTrials
Completed

NCT Number: NCT06376123

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University Dragos Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Alveolo-arterial gradient

    Time frame: 30 mins after intubation

    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.

Secondary outcomes

  1. Alveolo-arterial gradient change

    Time frame: After switching to one lung ventilation

    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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
Dec 24, 2025

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.

Published trials that share one or more normalized conditions with this study.