SuprAglottic Jet Ventilation vs High-flow Nasal Oxygen in Tubeless Laryngotracheal Surgery (AIRWAY)

SuprAglottic superImposed High Frequency Jet Ventilation veRsus High-flow nAsal oxYgen in Tubeless Laryngotracheal Surgery (AIRWAY): a Prospective Randomised Controlled Trial

This study aims to investigate two oxygenation methods (high flow nasal oxygen and supraglottic, superimposed high-frequency jet ventilation) for tubeless laryngotracheal surgeries concerning their safety and efficiency.

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Managment; Laryngotracheal Surgery
• Intervention / Treatment: Device: supraglottic superimposed high frequency jet ventilation ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany); Device: High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand)

Detailed Description

Eligible adult patients will be prepared for intubation according to the local SOPs of the anesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP, tcCO2, EEG, TOF and EIT.

Induction of anesthesia: Patients will be preoxygenated before induction of anesthesia for at least one minute through face-mask with FiO2 1.0 until etO2 reaches 0.9. The induction of anesthesia will be performed using a combination of sedative/hypnotic drugs, opioids and muscle relaxant.

The following medications will be mandatory as per protocol:

• A neuromuscular blocking agent (NMBA): Rocuronium 0.5-1 mg/kg
• Propofol 1-3 mg/kg
• Opioid: Fentanyl 1-3mcg/kg, Remifentanyl 1-3mcg/kg

After induction of anesthesia and the administration of a NMBA, bag-mask ventilation with FiO2 1.0 will be performed for at least 60 seconds or until the muscle relaxant is working. Full neuromuscular blockade will be assessed by train-of-four (TOF) monitoring. Anaesthesia will be given total intravenously with Propofol and Remifentanil under EEG guidance. Tracheal tube will be placed recruitment manoeuver (RM) will be performed before surgical disinfection. The RM consists of recruitment pressure of 30 cmH2O during 30 seconds. PEEP level will be set at 10cmH20.

Thereafter placement of the surgical laryngoscope will be performed by the ENT-surgeon and the oxygenation device according to randomization will be installed. The patient will be extubated and the intervention start.

Jet ventilation Group (intervention-group): Patients will receive supraglottic superimposed high frequency jet ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany), that will be directly attached to the operative suspension laryngoscope with a Luer-lock. Before use, pressure safety limits of the device will be tested. Initially FiO2 will remain at 1.0, FiO2 will be reduced to 0.3 during laser interventions. Frequency and pressure will be set according to the local standards.

High-Flow Oxygen Group (control-group): Patients will receive high-flow oxygen (up to 70 L/min FiO2 1.0) via nasal cannula with the Optiflow (Fisher & Paykel Healthcare, Auckland, New Zealand). FiO2 will remain at 1.0, FiO2 will be reduced to 0.3 during laser interventions.

If the measured SpO2 falls below 80%, or if the measured tcCO2 rises above 70mmHg, surgical procedures will be interrupted. Additionally, if deemed necessary, rescue strategies will be performed at the discretion of the attending anesthesiologist, even if the predefined thresholds are not crossed. Rescue oxygenation or decarboxylation will be provided, this may include increasing the FiO2 to 100% or performing tracheal tube placement by the surgeon, determined by the anaesthesiologist in charge. If this change in airway strategy remains unsuccessful, the local difficult airway algorithm will be followed according to the SOP.

If the rescue airway management was successful and respiratory parameters return to baseline levels, the initial airway device according to randomisation will be reapplied. A permanent switch of airway strategy leads to study termination.

EIT will be measured using PulmoVista® 500 by Dräger, Lübeck, Germany, to visualize possible atelectasis formation and its progression over time. EIT is a non-invasive, radiation-free technique for the assessment of spatial and temporal ventilation distribution based on the changes in electrical properties of the tissue during the respiratory cycle. EIT measurements will be performed using a commercially available setup (PulmoVista 500, Draeger, Germany). A loose-fitting belt with 16 evenly spaced electrodes will be placed around the participant's chest in thoracic median plane. Small electrical currents are injected through adjacent electrodes in a rotating mode. Resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized newton-raphson reconstruction algorithm. The device is suitable for assessment of jet ventilation and high flow.

Thoracic electrical impedance tomography measurements (each measurement will last 1 min) will be performed at the following time points: before induction of the anaesthesia; before the surgical procedure when the induction is terminated and recruitment manoeuvers have been performed; after the termination of the surgical procedure; before transport to the Post anaesthesia Care Unit (PACU); before the discharge from the PACU after 2 hours of monitoring. Relative change in poorly ventilated lung. regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated as described previously, using customised code (Matlab R2021a, The MathWorks, Nattick, Massachusetts, USA).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Fuchs, PD MD; Phone Number: +41 31 632 52 01; Email: alexander.fuchs@insel.ch
• Study Contact Backup: Name: Thomas Riva, Prof. MD; Phone Number: +41 31 632 17 09; Email: thomasriva@me.com

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent
• Patients aged ≥18 years
• Patients requiring elective tubeless laryngotracheal surgery

Exclusion Criteria:

• Patients <18 years
• High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Supraglottic, superimposed high frequency jet ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany) with initial 1.0 FiO2 reduced to 0.3 during laser surgery	Device: supraglottic superimposed high frequency jet ventilation ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany); supraglottic superimposed high frequency jet ventilation ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany). Initially FiO2 at 1.0, reduced to 0.3 during laser interventions. Frequency and pressure set according to the local standards
Active Comparator: Control group; high-flow oxygen (up to 70 L/min FiO2 1.0) via nasal cannula with the Optiflow (Fisher & Paykel Healthcare, Auckland, New Zealand) with initial 1.0 FiO2 reduced to 0.3 during laser surgery	Device: High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand); up to 70 L/min FiO2 1.0 high flow oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand) initially. Reduced FiO2 to 0.3 during laser intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall number of cases without interruptions	Number of cases using SSHFJV vs HFNO without interruption of the surgical procedure for rescue, during tubeless laryngo-tracheal surgery from placement of the laryngoscope to end of surgery.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until desaturation	Time until desaturation starting with laser surgery	2 hours
Reason for change of airway strategy	Reason for change of airway strategy given by the attending	5 minutes
Duration of interruptions	Duration of surgical interruptions to permit rescue	15 minutes
Number of interruptions	Number of surgical interruptions to permit rescue	5 minutes
Overall anesthesia time	Overall anesthesia time	3 hours
Duration of desaturation	Duration of desaturation (SpO2 <80%)	5 minutes
Overall surgery time	Overall surgery time	2 hours
Duration of hypercapnia	Duration of hypercapnia (>70mmHg)	5 minutes
Value of oxygen level	Value of lowest recorded SpO2 in %	5 minutes
Value of carbon dioxide level	Value of highest recorded tcCO2 in mmHg	5 minutes
Respiratory complications	Number of occurrences of respiratory complications before PACU-discharge and within 24 hours postoperatively, such as airway injury, cardiopulmonary resuscitation, bleeding, aspiration of gastric contents, post-extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded. Respiratory complications are defined as the need for re-intubation after being extubated, persistent stridor (even if oxygen is not required), respiratory failure, the occurrence of pneumothorax or the need for any additional diagnostic examination following respiratory problems (i.e., bronchoscopy, radiology).	24 hours
End-expiratory lung impedance (EELI) after the end of induction before the surgical procedure.	End-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) after the end of induction before the surgical procedure.	1 hour
End-expiratory lung impedance (EELI) at the end of the surgical procedure.	End-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) at the end of the surgical procedure.	3 hours
End-expiratory lung impedance (EELI) after the end of anaesthesia.	End-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.	3 hours
End-expiratory lung impedance (EELI) before discharge of PACU.	End-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).	5 hours
Changes in silent spaces after the end of induction before the surgical procedure.	Proportion of poorly ventilated lung areas (silent spaces) detected by using after the end of induction before the surgical procedure.	1 hour
Changes in silent spaces after the end of anaesthesia.	Proportion of poorly ventilated lung areas (silent spaces) detected by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.	3 hours
Changes in silent spaces at the end of the surgical procedure.	Proportion of poorly ventilated lung areas (silent spaces) detected by using electrical impedance tomography (EIT) at the end of the surgical procedure.	3 hours
Changes in silent spaces before discharge of PACU.	Proportion of poorly ventilated lung areas (silent spaces) detected by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).	5 hours
Ventilation inhomogeneity after the end of anaesthesia.	Ventilation inhomogeneity detected by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.	3 hours
Ventilation inhomogeneity before discharge of PACU.	Ventilation inhomogeneity detected by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).	5 hours
Ventilation inhomogeneity after the end of induction before the surgical procedure.	Ventilation inhomogeneity detected by using electrical impedance tomography (EIT) after the end of induction before the surgical procedure.	1 hour

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Alexander Fuchs, PD MD, University of Bern

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AIRWAY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No