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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06609915
Acronym
AIRWAY
Enrollment
40
Registered
2024-09-24
Start date
2026-10-01
Completion date
2029-04-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Managment, Laryngotracheal Surgery

Brief summary

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.

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 TwinStream EVO (Carl Reiner GmbH, Vienna, Austria), that will be directly attached to the operative suspension laryngoscope. 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).

Interventions

DEVICEsupraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria)

supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria). Initially FiO2 at 1.0, reduced to 0.3 during laser interventions. Frequency and pressure set according to the local standards

DEVICEHigh-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.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Randomised controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall number of cases without interruptions2 hoursNumber 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.

Secondary

MeasureTime frameDescription
Time until desaturation2 hoursTime until desaturation starting with laser surgery
Reason for change of airway strategy5 minutesReason for change of airway strategy given by the attending
Duration of interruptions15 minutesDuration of surgical interruptions to permit rescue
Number of interruptions5 minutesNumber of surgical interruptions to permit rescue
Overall anesthesia time3 hoursOverall anesthesia time
Duration of desaturation5 minutesDuration of desaturation (SpO2 \<80%)
Overall surgery time2 hoursOverall surgery time
Duration of hypercapnia5 minutesDuration of hypercapnia (\>70mmHg)
Value of oxygen level5 minutesValue of lowest recorded SpO2 in %
Value of carbon dioxide level5 minutesValue of highest recorded tcCO2 in mmHg
Respiratory complications24 hoursNumber 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).
End-expiratory lung impedance (EELI) after the end of induction before the surgical procedure.1 hourEnd-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) after the end of induction before the surgical procedure.
End-expiratory lung impedance (EELI) at the end of the surgical procedure.3 hoursEnd-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) at the end of the surgical procedure.
End-expiratory lung impedance (EELI) after the end of anaesthesia.3 hoursEnd-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.
End-expiratory lung impedance (EELI) before discharge of PACU.5 hoursEnd-expiratory lung impedance (EELI) detected by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).
Changes in silent spaces after the end of induction before the surgical procedure.1 hourProportion of poorly ventilated lung areas (silent spaces) detected by using after the end of induction before the surgical procedure.
Changes in silent spaces after the end of anaesthesia.3 hoursProportion 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.
Changes in silent spaces at the end of the surgical procedure.3 hoursProportion of poorly ventilated lung areas (silent spaces) detected by using electrical impedance tomography (EIT) at the end of the surgical procedure.
Changes in silent spaces before discharge of PACU.5 hoursProportion 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).
Ventilation inhomogeneity after the end of anaesthesia.3 hoursVentilation inhomogeneity detected by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.
Ventilation inhomogeneity before discharge of PACU.5 hoursVentilation inhomogeneity detected by using electrical impedance tomography (EIT) before the discharge from PACU (two hours after admission to PACU).
Ventilation inhomogeneity after the end of induction before the surgical procedure.1 hourVentilation inhomogeneity detected by using electrical impedance tomography (EIT) after the end of induction before the surgical procedure.

Countries

Switzerland

Contacts

CONTACTAlexander Fuchs, PD MD
alexander.fuchs@insel.ch+41 31 632 52 01
CONTACTThomas Riva, Prof. MD
thomasriva@me.com+41 31 632 17 09
PRINCIPAL_INVESTIGATORAlexander Fuchs, PD MD

University of Bern

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026