Respiratory Physiological PhenomenaNCT03973294
Assessment of Regional Lung Ventilation Distribution During Supraglottic and Subglottic Jet Ventilation by EIT.
A study testing EIT-measurement in people with Respiratory Physiological Phenomena, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Respiratory Physiological Phenomena
- What is being tested?
- EIT-measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jun 2019to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Regional Lung Ventilation Distribution During Supraglottic and Subglottic Jet Ventilation by Electrical Impedance Tomography (EIT).
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.
Read more
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.
Read the detailed description
Surgical procedures of the larynx and trachea present special challenges for surgeons and anesthesiologists. To enable an unrestricted view of the operating field, ventilation of the patient is not performed over an endotracheal tube but instead over a steel laryngoscope or a thin catheter with Jet ventilation (JV). This enables precision surgical work, good visibility of the operating area and the safe use of various laser types. Over the last decades, different modalities of JV for laryngo-tracheal surgery have been developed. The former techniques of the supraglottic approach were improved with simultaneously applied low-frequency jet ventilation additionally to the high-frequency jet ventilation, called superimposed high-frequency jet ventilation (SHFJV). The SHFJV was developed in 1990 and was applied in several clinical trials [1-4] In recent years, a number of new catheters have been developed for the trans laryngeal subglottic approach of JV, like the translaryngeal Hunsaker MonJet Ventilation catheter and its successor, the LaserJet catheter. These catheters though can be used only with the HFJV. They provide less vocal cord movement and precise surgical manipulation are possible on one side, but on the other the risk of barotrauma may result in cases of proximal obstruction of the catheter.
[5, 6] Although jet ventilation is an established method to replace patients breathing during otorhinolaryngeal surgery, research is still required on efficient lung protective ventilation in order to provide adequate carbon dioxide (CO2) elimination, adequate oxygenation and in preventing ventilator induced lung injury. Jet ventilation techniques and access routes The TwinStream jet ventilator (C. Reiner Corp, Vienna, Austria) is routinely used for high-frequency jet ventilation (HFJV) or SHFJV in case of tubeless jet laryngoscopy (laryngeal micro- and laser surgery) and tracheoscopy. The device consists of two simultaneously operating ventilation units which can be adjusted separately. The driving pressure of the device is 1.5-3 bar and respiratory rates of 10-900 per min can be provided. Supraglottic jet laryngoscope In 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, with the low-frequency jet stream passing the distal cannula, and the high-frequency jet stream at the proximal cannula. A third cannula at the tip of the laryngoscope allows ventilation pressure monitoring. The jet laryngoscope is introduced by the surgeon, for examining and operating structures within the laryngotracheal system. Supraglottic JV causes more laryngeal movement induced by disturbances through the high frequent inspiratory air passing the operating field compared to the subglottic jet ventilation. [9] Furthermore it leads to greater dryness of the vocal cords. During supraglottic SHFJV the escaping exhaled gases vent blood and secretion outward, reducing the risk of fluid aspiration and of displacing cells of any entity down to the tracheobronchial tree.
Advantages of SHFJV with the supraglottic inserted steel laryngoscope:
- Unlimited surgical access and vision of the operating field
- Laser resistant
- Protection of the airway through the inherent 'auto-PEEP (positive endexpiratory pressure)' effect
- Prevention of CO2 retention, lung alveolar collapse and improvement of the oxygen index Subglottic LaserJet Catheter Through the LaserJet catheter ventilation is performed only with HFJV. 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".
The LaserJet catheter (C. Reiner Corp, Vienna, Austria) is made of polyterafluoroethylene and is non inflammable and provides a good micro anatomical overview of the operating structures [7,8,9] However, the LaserJet catheter is not laser resistant in regards of deformation damage (perforation) under direct exposure to a continuous laser beam. The use of the new 445 nm wavelength laser, the 'blue laser' eases the surgical performance by securing important laryngeal functionality even in advanced disease [3,4,10] While the exposure of the complete pathology is visualized and treated, the surrounding tissue is not dislocated or deformed.
[11] The LaserJet catheter has the advantage of minimizing movements of the larynx and vocal cords and facilitates the precise use of the blue laser without affecting healthy tissue.
Electrical impedance tomography (EIT) When evaluating different JV devices and techniques, tidal volume and minute ventilation are difficult to assess because SHFJV and HFJV are applied in an open airway system. Air entrainment occurs to a varying extent depending on the route of JV administration, anatomical factors and jet alignment with the airway. [13] A standard intraoperative monitoring does not provide accurate predictions about changes in regional lung ventilation. 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. Analyzing EIT measurements during ongoing mechanical JV is a useful tool to detect imbalances in regional lung ventilation and in further consequence enables to optimize ventilator setting during surgery. The investigators will assess changes in regional lung ventilation distribution during supra- and subglottic JV compared to controlled mask ventilation. EIT, as a non-invasive method, may become a useful tool for adjustment of optimal positioning of the JV devices and for decision-making of the optimal type of the JV device (supraglottic laryngoscope versus subglottic jet catheter) by detecting atelectasis as "silent spaces" or over distension. This additional source of information could help fine tune the jet ventilator. Its intraoperative use could provide the basis for individual optimization of jet ventilator settings, especially in patients at risk for ventilation-perfusion mismatch and impaired gas exchange. Serological biomarkers of lung damage and inflammation It is still an open question whether the type of specific mechanical ventilation like HFJV and SHFJV have an influence on changes in serological biomarkers for lung damage and inflammation like Surfactant proteins (SP)-D [14-16], Krebs van den Lungen (KL)-6 [17, 18], Clara cell protein (CC16) [19, 20], Adrenomedullin (ADM) [21] or Interleukin 6 (IL-6) and 8 (IL-8). Studies revealed that in patients with normal lungs, relatively short periods of mechanical ventilation induce lung inflammation and that these changes depend on the ventilatory parameters applied. [22-25] The investigators will study the influence of JV on these serum levels in patients undergoing elective laryngotracheal surgery. Specific aims and hypotheses The objective of this study is to compare regional ventilation distribution, blood gas oxygenation, CO2 elimination and serum biomarkers with different jet ventilatory techniques and access routes.
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 secondary objective of the study is to investigate changes in ventro-dorsal ventilation distribution, measured as ventro-dorsal COV shift, under subglottic JV compared to standardized, controlled mask ventilation. Further study objectives are the comparison of ventilation distribution parameters between the two JV techniques, supra- and subglottic JV, and the analysis of oxygenation and CO2 elimination during these two ventilation modes over time. Furthermore, special serum biomarkers of pulmonary lung damage are determined after JV application. Primary hypothesis The primary hypothesis is that during the use of supraglottic jet ventilation, the COV is shifted to more ventrally located (non-dependent) lung sections compared to controlled mask ventilation.
Secondary hypothesis The secondary hypothesis is that subglottic JV ventilation leads to a ventral displacement of the COV compared to controlled mask ventilation and that this occurs to a greater extent than during supraglottic JV. Null hypothesis There is no significant displacement of COV into ventrally located lung sections under supraglottic jet ventilation compared to controlled mask ventilation.
- Conditions
- Respiratory Physiological Phenomena
- Being tested
- EIT-measurement
- Keywords
- jet ventilation, electroimpedance tomography, supraglottic jet ventilation, subglottic jet ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-measurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: Device: EIT-measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Sum of impedance changes in predefined regions of interest (ROI) 1-4
Measured: 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
Changes in end expiratory lung impedance
Measured: 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
Areas with impedance changes <10%.
Measured: 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
PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2 index) are investigated over time during mask ventilation, supra- and subglottic JV
Measured: 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
IL-6, IL-8, SP-D, KL-6, CC16, ADM) are determined preoperatively and postoperatively at fixed points
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start7 Jun 2019
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Respiratory Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Windpassinger M.D., Medical University of Vienna
- Investigators
- Marita Windpassinger, MD, MBA, Principal investigator, Medical University of ViennaOlga Plattner, MD, Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973294
- Sponsor's protocol ID
- 1298/2019
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bacher A, Lang T, Weber J, Aloy A. Respiratory efficacy of subglottic low-frequency, subglottic combined-frequency, and supraglottic combined-frequency jet ventilation during microlaryngeal surgery. Anesth Analg. 2000 Dec;91(6):1506-12. doi: 10.1097/00000539-200012000-00039.
PubMed 11094009Bacher A, Pichler K, Aloy A. Supraglottic combined frequency jet ventilation versus subglottic monofrequent jet ventilation in patients undergoing microlaryngeal surgery. Anesth Analg. 2000 Feb;90(2):460-5. doi: 10.1097/00000539-200002000-00041.
PubMed 10648340Lanzenberger-Schragl E, Donner A, Grasl MC, Zimpfer M, Aloy A. Superimposed high-frequency jet ventilation for laryngeal and tracheal surgery. Arch Otolaryngol Head Neck Surg. 2000 Jan;126(1):40-4. doi: 10.1001/archotol.126.1.40.
PubMed 10628709Rezaie-Majd A, Bigenzahn W, Denk DM, Burian M, Kornfehl J, Grasl MCh, Ihra G, Aloy A. Superimposed high-frequency jet ventilation (SHFJV) for endoscopic laryngotracheal surgery in more than 1500 patients. Br J Anaesth. 2006 May;96(5):650-9. doi: 10.1093/bja/ael074. Epub 2006 Mar 30.
PubMed 16574723Davies JM, Hillel AD, Maronian NC, Posner KL. The Hunsaker Mon-Jet tube with jet ventilation is effective for microlaryngeal surgery. Can J Anaesth. 2009 Apr;56(4):284-90. doi: 10.1007/s12630-009-9057-2. Epub 2009 Feb 25.
PubMed 19296189Frochaux D, Rajan GP, Biro P. [Laser-resistance of a new jet ventilation catheter (LaserJet) under simulated clinical conditions]. Anaesthesist. 2004 Sep;53(9):820-5. doi: 10.1007/s00101-004-0717-x. German.
PubMed 15448938Friedrich G, Mausser G, Gugatschka M. [Jet ventilation in laryngotracheal surgery]. HNO. 2008 Dec;56(12):1197-206. doi: 10.1007/s00106-008-1725-y. German.
PubMed 19020846Wegrzynowicz ES, Jensen NF, Pearson KS, Wachtel RE, Scamman FL. Airway fire during jet ventilation for laser excision of vocal cord papillomata. Anesthesiology. 1992 Mar;76(3):468-9. doi: 10.1097/00000542-199203000-00022. No abstract available.
PubMed 1539860Rubin JS, Patel A, Lennox P. Subglottic jet ventilation for suspension microlaryngoscopy. J Voice. 2005 Mar;19(1):146-50. doi: 10.1016/j.jvoice.2004.03.008.
PubMed 15766860Hess MM, Fleischer S, Ernstberger M. New 445 nm blue laser for laryngeal surgery combines photoangiolytic and cutting properties. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1557-1567. doi: 10.1007/s00405-018-4974-8. Epub 2018 Apr 19.
PubMed 29675755Helmstaedter V, Tellkamp R, Schwab B, Lenarz T, Durisin M. [High-frequency jet ventilation in otorhinolaryngology - surgical and anaesthesiologic issues]. Laryngorhinootologie. 2014 Jul;93(7):455-60. doi: 10.1055/s-0034-1370925. Epub 2014 Mar 27. German.
PubMed 24676871Jaquet Y, Monnier P, Van Melle G, Ravussin P, Spahn DR, Chollet-Rivier M. Complications of different ventilation strategies in endoscopic laryngeal surgery: a 10-year review. Anesthesiology. 2006 Jan;104(1):52-9. doi: 10.1097/00000542-200601000-00010.
PubMed 16394690Heinze H, Eichler W, Karsten J, Sedemund-Adib B, Heringlake M, Meier T. Functional residual capacity-guided alveolar recruitment strategy after endotracheal suctioning in cardiac surgery patients. Crit Care Med. 2011 May;39(5):1042-9. doi: 10.1097/CCM.0b013e31820eb736.
PubMed 21336125Greene KE, King TE Jr, Kuroki Y, Bucher-Bartelson B, Hunninghake GW, Newman LS, Nagae H, Mason RJ. Serum surfactant proteins-A and -D as biomarkers in idiopathic pulmonary fibrosis. Eur Respir J. 2002 Mar;19(3):439-46. doi: 10.1183/09031936.02.00081102.
PubMed 11936520Haagsman HP, Hogenkamp A, van Eijk M, Veldhuizen EJ. Surfactant collectins and innate immunity. Neonatology. 2008;93(4):288-94. doi: 10.1159/000121454. Epub 2008 Jun 5.
PubMed 18525212
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Regional Lung Ventilation Distribution During Supraglottic and Subglottic Jet Ventilation by Electrical Impedance Tomography (EIT).
- ClinicalTrials.gov ID
- NCT03973294
- Acronym / sponsor ID
- 1298/2019
- Conditions
- Respiratory Physiological Phenomena
- Keywords
- jet ventilation, electroimpedance tomography, supraglottic jet ventilation, subglottic jet ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgical procedures of the larynx and trachea present special challenges for surgeons and anesthesiologists. To enable an unrestricted view of the operating field, ventilation of the patient is not performed over an endotracheal tube but instead over a steel laryngoscope or a thin catheter with Jet ventilation (JV). This enables precision surgical work, good visibility of the operating area and the safe use of various laser types. Over the last decades, different modalities of JV for laryngo-tracheal surgery have been developed. The former techniques of the supraglottic approach were improved with simultaneously applied low-frequency jet ventilation additionally to the high-frequency jet ventilation, called superimposed high-frequency jet ventilation (SHFJV). The SHFJV was developed in 1990 and was applied in several clinical trials [1-4] In recent years, a number of new catheters have been developed for the trans laryngeal subglottic approach of JV, like the translaryngeal Hunsaker MonJet Ventilation catheter and its successor, the LaserJet catheter. These catheters though can be used only with the HFJV. They provide less vocal cord movement and precise surgical manipulation are possible on one side, but on the other the risk of barotrauma may result in cases of proximal obstruction of the catheter.
[5, 6] Although jet ventilation is an established method to replace patients breathing during otorhinolaryngeal surgery, research is still required on efficient lung protective ventilation in order to provide adequate carbon dioxide (CO2) elimination, adequate oxygenation and in preventing ventilator induced lung injury. Jet ventilation techniques and access routes The TwinStream jet ventilator (C. Reiner Corp, Vienna, Austria) is routinely used for high-frequency jet ventilation (HFJV) or SHFJV in case of tubeless jet laryngoscopy (laryngeal micro- and laser surgery) and tracheoscopy. The device consists of two simultaneously operating ventilation units which can be adjusted separately. The driving pressure of the device is 1.5-3 bar and respiratory rates of 10-900 per min can be provided. Supraglottic jet laryngoscope In 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, with the low-frequency jet stream passing the distal cannula, and the high-frequency jet stream at the proximal cannula. A third cannula at the tip of the laryngoscope allows ventilation pressure monitoring. The jet laryngoscope is introduced by the surgeon, for examining and operating structures within the laryngotracheal system. Supraglottic JV causes more laryngeal movement induced by disturbances through the high frequent inspiratory air passing the operating field compared to the subglottic jet ventilation. [9] Furthermore it leads to greater dryness of the vocal cords. During supraglottic SHFJV the escaping exhaled gases vent blood and secretion outward, reducing the risk of fluid aspiration and of displacing cells of any entity down to the tracheobronchial tree.
Advantages of SHFJV with the supraglottic inserted steel laryngoscope:
- Unlimited surgical access and vision of the operating field
- Laser resistant
- Protection of the airway through the inherent 'auto-PEEP (positive endexpiratory pressure)' effect
- Prevention of CO2 retention, lung alveolar collapse and improvement of the oxygen index Subglottic LaserJet Catheter Through the LaserJet catheter ventilation is performed only with HFJV. 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".
The LaserJet catheter (C. Reiner Corp, Vienna, Austria) is made of polyterafluoroethylene and is non inflammable and provides a good micro anatomical overview of the operating structures [7,8,9] However, the LaserJet catheter is not laser resistant in regards of deformation damage (perforation) under direct exposure to a continuous laser beam. The use of the new 445 nm wavelength laser, the 'blue laser' eases the surgical performance by securing important laryngeal functionality even in advanced disease [3,4,10] While the exposure of the complete pathology is visualized and treated, the surrounding tissue is not dislocated or deformed.
[11] The LaserJet catheter has the advantage of minimizing movements of the larynx and vocal cords and facilitates the precise use of the blue laser without affecting healthy tissue.
Electrical impedance tomography (EIT) When evaluating different JV devices and techniques, tidal volume and minute ventilation are difficult to assess because SHFJV and HFJV are applied in an open airway system. Air entrainment occurs to a varying extent depending on the route of JV administration, anatomical factors and jet alignment with the airway. [13] A standard intraoperative monitoring does not provide accurate predictions about changes in regional lung ventilation. 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. Analyzing EIT measurements during ongoing mechanical JV is a useful tool to detect imbalances in regional lung ventilation and in further consequence enables to optimize ventilator setting during surgery. The investigators will assess changes in regional lung ventilation distribution during supra- and subglottic JV compared to controlled mask ventilation. EIT, as a non-invasive method, may become a useful tool for adjustment of optimal positioning of the JV devices and for decision-making of the optimal type of the JV device (supraglottic laryngoscope versus subglottic jet catheter) by detecting atelectasis as "silent spaces" or over distension. This additional source of information could help fine tune the jet ventilator. Its intraoperative use could provide the basis for individual optimization of jet ventilator settings, especially in patients at risk for ventilation-perfusion mismatch and impaired gas exchange. Serological biomarkers of lung damage and inflammation It is still an open question whether the type of specific mechanical ventilation like HFJV and SHFJV have an influence on changes in serological biomarkers for lung damage and inflammation like Surfactant proteins (SP)-D [14-16], Krebs van den Lungen (KL)-6 [17, 18], Clara cell protein (CC16) [19, 20], Adrenomedullin (ADM) [21] or Interleukin 6 (IL-6) and 8 (IL-8). Studies revealed that in patients with normal lungs, relatively short periods of mechanical ventilation induce lung inflammation and that these changes depend on the ventilatory parameters applied. [22-25] The investigators will study the influence of JV on these serum levels in patients undergoing elective laryngotracheal surgery. Specific aims and hypotheses The objective of this study is to compare regional ventilation distribution, blood gas oxygenation, CO2 elimination and serum biomarkers with different jet ventilatory techniques and access routes.
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 secondary objective of the study is to investigate changes in ventro-dorsal ventilation distribution, measured as ventro-dorsal COV shift, under subglottic JV compared to standardized, controlled mask ventilation. Further study objectives are the comparison of ventilation distribution parameters between the two JV techniques, supra- and subglottic JV, and the analysis of oxygenation and CO2 elimination during these two ventilation modes over time. Furthermore, special serum biomarkers of pulmonary lung damage are determined after JV application. Primary hypothesis The primary hypothesis is that during the use of supraglottic jet ventilation, the COV is shifted to more ventrally located (non-dependent) lung sections compared to controlled mask ventilation.
Secondary hypothesis The secondary hypothesis is that subglottic JV ventilation leads to a ventral displacement of the COV compared to controlled mask ventilation and that this occurs to a greater extent than during supraglottic JV. Null hypothesis There is no significant displacement of COV into ventrally located lung sections under supraglottic jet ventilation compared to controlled mask ventilation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Supraglottic jet ventilation | Active comparator | Device: EIT-measurementVentilation 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. |
| Subglottic jet ventilation | Active comparator | Device: EIT-measurementSubglottic 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". |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT-measurementThe 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. | Device | Subglottic jet ventilation, Supraglottic jet ventilation |
Primary outcome
Center of ventilation (COV)
Time frame: 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.
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.
5 secondary outcomes
ROI 1-4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 11094009Bacher A, Lang T, Weber J, Aloy A. Respiratory efficacy of subglottic low-frequency, subglottic combined-frequency, and supraglottic combined-frequency jet ventilation during microlaryngeal surgery. Anesth Analg. 2000 Dec;91(6):1506-12. doi: 10.1097/00000539-200012000-00039.
- Background: PubMed 10648340Bacher A, Pichler K, Aloy A. Supraglottic combined frequency jet ventilation versus subglottic monofrequent jet ventilation in patients undergoing microlaryngeal surgery. Anesth Analg. 2000 Feb;90(2):460-5. doi: 10.1097/00000539-200002000-00041.
- Background: PubMed 10628709Lanzenberger-Schragl E, Donner A, Grasl MC, Zimpfer M, Aloy A. Superimposed high-frequency jet ventilation for laryngeal and tracheal surgery. Arch Otolaryngol Head Neck Surg. 2000 Jan;126(1):40-4. doi: 10.1001/archotol.126.1.40.
- Background: PubMed 16574723Rezaie-Majd A, Bigenzahn W, Denk DM, Burian M, Kornfehl J, Grasl MCh, Ihra G, Aloy A. Superimposed high-frequency jet ventilation (SHFJV) for endoscopic laryngotracheal surgery in more than 1500 patients. Br J Anaesth. 2006 May;96(5):650-9. doi: 10.1093/bja/ael074. Epub 2006 Mar 30.
- Background: PubMed 19296189Davies JM, Hillel AD, Maronian NC, Posner KL. The Hunsaker Mon-Jet tube with jet ventilation is effective for microlaryngeal surgery. Can J Anaesth. 2009 Apr;56(4):284-90. doi: 10.1007/s12630-009-9057-2. Epub 2009 Feb 25.
- Background: PubMed 15448938Frochaux D, Rajan GP, Biro P. [Laser-resistance of a new jet ventilation catheter (LaserJet) under simulated clinical conditions]. Anaesthesist. 2004 Sep;53(9):820-5. doi: 10.1007/s00101-004-0717-x. German.
- Background: PubMed 19020846Friedrich G, Mausser G, Gugatschka M. [Jet ventilation in laryngotracheal surgery]. HNO. 2008 Dec;56(12):1197-206. doi: 10.1007/s00106-008-1725-y. German.
- Background: PubMed 1539860Wegrzynowicz ES, Jensen NF, Pearson KS, Wachtel RE, Scamman FL. Airway fire during jet ventilation for laser excision of vocal cord papillomata. Anesthesiology. 1992 Mar;76(3):468-9. doi: 10.1097/00000542-199203000-00022. No abstract available.
- Background: PubMed 15766860Rubin JS, Patel A, Lennox P. Subglottic jet ventilation for suspension microlaryngoscopy. J Voice. 2005 Mar;19(1):146-50. doi: 10.1016/j.jvoice.2004.03.008.
- Background: PubMed 29675755Hess MM, Fleischer S, Ernstberger M. New 445 nm blue laser for laryngeal surgery combines photoangiolytic and cutting properties. Eur Arch Otorhinolaryngol. 2018 Jun;275(6):1557-1567. doi: 10.1007/s00405-018-4974-8. Epub 2018 Apr 19.
- Background: PubMed 24676871Helmstaedter V, Tellkamp R, Schwab B, Lenarz T, Durisin M. [High-frequency jet ventilation in otorhinolaryngology - surgical and anaesthesiologic issues]. Laryngorhinootologie. 2014 Jul;93(7):455-60. doi: 10.1055/s-0034-1370925. Epub 2014 Mar 27. German.
- Background: PubMed 16394690Jaquet Y, Monnier P, Van Melle G, Ravussin P, Spahn DR, Chollet-Rivier M. Complications of different ventilation strategies in endoscopic laryngeal surgery: a 10-year review. Anesthesiology. 2006 Jan;104(1):52-9. doi: 10.1097/00000542-200601000-00010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marita Windpassinger, MD, MBA principal investigator
Medical University of Vienna
Olga Plattner, MD study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-measurement in people with Respiratory Physiological Phenomena, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of ventilation (COV) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973294, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.