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

NCT03973294 | Completed

• 1 other identifier: 1298/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

jet ventilation; electroimpedance tomography; supraglottic jet ventilation; subglottic jet ventilation

Outcome Measures

Primary Outcomes (1)

• Center of ventilation (COV)

  Our primary aim is to determine whether supraglottic JV with the jet laryngoscope leads to a shift of the Center of Ventilation (COV) towards the ventral lungs compared to mask ventilation.

  The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.

Secondary Outcomes (5)

• ROI 1-4

  The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.

• ΔEELI

  The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.

• silent spaces

  The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.

• Blood gas analysis values

  Blood will be drawn during mask ventilation, 5 minutes after supraglottic and 5 minutes after subglottic JV and at the end of surgery, before leaving to the recovery room for gas analysis and serum biomarkers.

• Special serum biomarkers for pulmonary inflammation and parenchyma damage

  Blood will be drawn during mask ventilation, 5 minutes after supraglottic and 5 minutes after subglottic JV and at the end of surgery, before leaving to the recovery room for gas analysis and serum biomarkers.

Study Arms (2)

Supraglottic jet ventilation

ACTIVE COMPARATOR

Ventilation of the patient is performed over a steel laryngoscope or a thin catheter by means of jet ventilation (JV) using the TwinStream jet ventilator (C. Reiner Corp, Vienna, Austria). The driving pressure of the device is 1.5-3 bar and respiratory rates of 10-900 per min can be provided. In superimposed high frequency jet ventilation (SHFJV), jet ventilation of normal frequency and high frequency is conducted simultaneously and enables ventilation at two different pressure levels through the steel jet laryngoscope. It is equipped with two jet nozzles, which are placed at the distal end of the jet laryngoscope.

Device: EIT-measurement

Subglottic jet ventilation

ACTIVE COMPARATOR

Subglottic HFJV is performed through the LaserJet catheter. It is characterized by the delivery of small tidal volumes from a high pressure jet at very high frequencies (100-400) followed by passive expiration for a very short period before delivering the next jet, creating an "auto-PEEP".

Device: EIT-measurement

Interventions

EIT-measurement DEVICE

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.

Subglottic jet ventilation; Supraglottic jet ventilation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective micro-laryngotracheal surgery
• Ventilation type: SHFJV and HFJV
• Jet devices: Jet laryngoscope and LaserJet catheter
• ASA 1-3
• Age 18- 99 years.

You may not qualify if:

• acute bleeding in the area of the larynx/trachea
• infectious lung disease (e.g. tuberculosis)
• inability to perform retroflexion of the head (laryngoscope cannot be positioned properly)
• thoracic wall deformities
• obesity, BMI \>30kg/m2
• implantable electronic devices (f.e. pacemaker, ICD)
• emergency surgery
• expected postoperative mechanical ventilation (Intensive Care Unit)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

Related Publications (25)

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Study Officials

• Marita Windpassinger, MD, MBA

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Olga Plattner, MD

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 4, 2019
• Study Start: June 7, 2019
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)