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Assessment of Regional Lung Ventilation Distribution During Supraglottic and Subglottic Jet Ventilation by EIT.

NCT03973294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-30

No results posted yet for this study

Summary

Objective: To estimate regional lung volume changes by electrical impedance tomography (EIT) during supra- and subglottic jet ventilation via the jet laryngoscope and LaserJet catheter for performing laryngotracheal surgery.

Design: A monocentric, prospective, randomized study. Patients: Patients who require elective micro laryngo-tracheal surgery under jet ventilation.

Interventions: Patients undergoing elective micro laryngeal surgery will be assigned to subglottic JV via the new LaserJet catheter and supraglottic JV via the jet laryngoscope vice versa. The sequence of JV modes will be randomized (subglottic followed by supraglottic or supraglottic followed by subglottic JV). Hemodynamic and ventilation parameters will be monitored. Arterial blood gas samples will be drawn and the regional ventilation distribution assessed, using the EIT.

Outcomes measures: Reported EIT data of regional ventilation distribution, values of oxygenation and carbon dioxide elimination during the application of supra- and subglottic JV via jet laryngoscope and LaserJet catheter in patients undergoing laryngo-tracheal surgery. The purpose of this study is to investigate the influence of supraglottic and subglottic JV compared to standardized, controlled mask ventilation on measurements of pulmonary regional ventilation distribution by EIT, blood gas analyses and serological biomarkers.

Conditions

  • Respiratory Physiological Phenomena

Interventions

DEVICE

EIT-measurement

The use of electrical impedance tomography (EIT) (SentecTom BB2, Landquart, Switzerland) allows the investigators to obtain a visual and quantitative representation of the areas of ventilation and aeration of the lung. The fundamental principle of lung EIT relies on the application of small alternating electrical currents into the thorax and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation-free imaging method which has the advantage to reveal real-time information. An array of electrodes (textile belt with 32 integrated electrocardiographic electrodes) has to be placed around the thorax to inject currents and to measure the resulting voltages on the thoracic surface.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Marita Windpassinger, MD, MBA · Medical University of Vienna

  • Olga Plattner, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2023-08-21
Completion
2023-08-21

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973294 on ClinicalTrials.gov