NCT06376123

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

April 17, 2024

Last Update Submit

December 18, 2025

Conditions

Keywords

One lung ventilationAlveolo-arterial gradientNomograms

Outcome Measures

Primary Outcomes (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.

    30 mins after intubation

Secondary Outcomes (1)

  • Alveolo-arterial gradient change

    After switching to one lung ventilation

Study Arms (1)

Video assisted thoracoscopic surgery patients

Patients, assigned for elective lung surgery, older than 18 years and requiring one-lung ventilation.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University Dragos Hospital

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 34898701BACKGROUND
  • 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.

    PMID: 19417615BACKGROUND
  • 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.

    PMID: 31362907BACKGROUND

Study Officials

  • Nigar Kangarli, MD

    Anesthesiology and Reanimation Department, Specialist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Anesthesiologist

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 19, 2024

Study Start

June 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations