NCT04962581

Brief Summary

A prospective descriptive study of the use of an individualized capnography to each lung in the context of one-lung ventilation achieved with a double-lumen tube. \- Pilot project and proof of concept Brief Summary:

  • One study suggests a way to predict possible events of hypoxemia (Sat O2 \< 90%) during one lung ventilation (OLV) with the use of two individualized capnography devices on each lung during two-lung ventilation before inducing OLV.
  • In addition, a recent presentation in the 2021 Thoracic Anesthesia Symposium suggested possible benefits of the use of a capnography device on the non-ventilated lung in the detection of air leaks around the bronchial cuff.
  • The same presentation demonstrated the utility of EtCo2 measurement to determine the achievement of complete lung collapse. With these previous demonstrations, the use of an individualized capnography for each lung can potentially describe different steps during thoracic surgery. Therefore, a descriptive prospective study on patients that require thoracic surgery with use of a double lumen tube is proposed to verify the feasibility of dual capnography during OLV. The use of two different devices, randomized during our study, will also help to identify the impact of different air aspiration levels on our measures. Such results will allow to put forward prospective projects to help to optimize OLV during thoracic surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

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

Study Start

First participant enrolled

July 4, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

July 5, 2021

Last Update Submit

August 18, 2022

Conditions

Keywords

One lung ventilationLung collapseCapnographyDouble lumen tubeDLTThoracic surgeryVATSVideo-assistedVideo assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Characterize the expired CO2 during the different steps in one lung ventilation

    Characterize the expired CO2 during the different steps in one lung ventilation for both lungs: the isolated non-ventilated and the ventilated lung

    During Thoracic Surgery: From intubation to extubation

Secondary Outcomes (1)

  • Performance and reliability of two capnography machines on the measure of the expired carbon dioxide

    During Thoracic Surgery: From intubation to extubation

Study Arms (2)

Group 1 : Covidien

This cohort will be monitored with the Covidien capnography, which will be connected to the isolated non-ventilated lung during the whole procedure.

Group 2: General Électrique

This cohort will be monitored with the General Electrique capnography, which will be connected to the isolated non-ventilated lung during the whole procedure.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The Study population is all patients that require one-lung ventilation thoracic surgery with use of double-lumen tubes.

You may qualify if:

  • Use of double-lumen tubes for isolation of the lung
  • Elective unilateral lung resection (anatomical segmentectomy, lobectomy or pneumonectomy) for lung cancer

You may not qualify if:

  • Use of bronchial blockers
  • IMC above 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

  • Kiwakyou L. BJ. Free and Simple Confirmation of Lung Isolation adequacy. [Thoracic Anesthesia Symposium 2021, Poster Presentation #30]. In press 2021

    BACKGROUND
  • Yamamoto Y, Watanabe S, Kano T. Gradient of bronchial end-tidal CO2 during two-lung ventilation in lateral decubitus position is predictive of oxygenation disorder during subsequent one-lung ventilation. J Anesth. 2009;23(2):192-7. doi: 10.1007/s00540-008-0737-9. Epub 2009 May 15.

    PMID: 19444556BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Catherine Fortier

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 15, 2021

Study Start

July 4, 2021

Primary Completion

September 1, 2021

Study Completion

December 30, 2021

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations