Airway ManagmentAIRWAYNCT06609915
SuprAglottic Jet Ventilation vs High-flow Nasal Oxygen in Tubeless Laryngotracheal Surgery
A study testing supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) and High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand) in people with Airway Managment and Laryngotracheal Surgery, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Managment, Laryngotracheal Surgery
- What is being tested?
- supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) and High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Oct 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Patients aged ≥18 years
- Patients requiring elective tubeless laryngotracheal surgery
Who cannot join
- Patients <18 years
- High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
Inselspital
Bern, 3010
University Hospital Bern
Bern, 3010
About this study
Official title: 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.
Read the 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).
- Conditions
- Airway Managment, Laryngotracheal Surgery
- Being tested
- supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria), High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria)Device
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
High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Supraglottic, superimposed high frequency jet ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) with initial 1.0 FiO2 reduced to 0.3 during laser surgery Receives: Device: supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) |
| Control group | Active comparator | 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 Receives: Device: High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (22)
Time until desaturation
Time until desaturation starting with laser surgery
Measured: 2 hours
Reason for change of airway strategy
Reason for change of airway strategy given by the attending
Measured: 5 minutes
Duration of interruptions
Duration of surgical interruptions to permit rescue
Measured: 15 minutes
Number of interruptions
Number of surgical interruptions to permit rescue
Measured: 5 minutes
Overall anesthesia time
Overall anesthesia time
Measured: 3 hours
Duration of desaturation
Duration of desaturation (SpO2 <80%)
Measured: 5 minutes
Overall surgery time
Overall surgery time
Measured: 2 hours
Duration of hypercapnia
Duration of hypercapnia (>70mmHg)
Measured: 5 minutes
Value of oxygen level
Value of lowest recorded SpO2 in %
Measured: 5 minutes
Value of carbon dioxide level
Value of highest recorded tcCO2 in mmHg
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagmentStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Fuchs, PD MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609915
- Sponsor's protocol ID
- AIRWAY
- Acronym
- AIRWAY
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SuprAglottic superImposed High Frequency Jet Ventilation veRsus High-flow nAsal oxYgen in Tubeless Laryngotracheal Surgery (AIRWAY): a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06609915
- Acronym / sponsor ID
- AIRWAY / AIRWAY
- Conditions
- Airway Managment, Laryngotracheal Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 24 Sep 2024 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria)Supraglottic, superimposed high frequency jet ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) with initial 1.0 FiO2 reduced to 0.3 during laser surgery |
| Control group | Active comparator | Device: High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Patients aged ≥18 years
- Patients requiring elective tubeless laryngotracheal surgery
Key exclusion criteria (2 listed)
- Patients <18 years
- High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.
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 |
|---|---|---|
| supraglottic 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 | Device | Intervention group |
| 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. | Device | Control group |
Primary outcome
Overall number of cases without interruptions
Time frame: 2 hours
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.
22 secondary outcomes
Time until desaturation
Time frame: 2 hours
Reason for change of airway strategy
Time frame: 5 minutes
Duration of interruptions
Time frame: 15 minutes
Number of interruptions
Time frame: 5 minutes
Overall anesthesia time
Time frame: 3 hours
Duration of desaturation
Time frame: 5 minutes
Overall surgery time
Time frame: 2 hours
Duration of hypercapnia
Time frame: 5 minutes
Value of oxygen level
Time frame: 5 minutes
Value of carbon dioxide level
Time frame: 5 minutes
Respiratory complications
Time frame: 24 hours
End-expiratory lung impedance (EELI) after the end of induction before the surgical procedure.
Time frame: 1 hour
End-expiratory lung impedance (EELI) at the end of the surgical procedure.
Time frame: 3 hours
End-expiratory lung impedance (EELI) after the end of anaesthesia.
Time frame: 3 hours
End-expiratory lung impedance (EELI) before discharge of PACU.
Time frame: 5 hours
Changes in silent spaces after the end of induction before the surgical procedure.
Time frame: 1 hour
Changes in silent spaces after the end of anaesthesia.
Time frame: 3 hours
Changes in silent spaces at the end of the surgical procedure.
Time frame: 3 hours
Changes in silent spaces before discharge of PACU.
Time frame: 5 hours
Ventilation inhomogeneity after the end of anaesthesia.
Time frame: 3 hours
Ventilation inhomogeneity before discharge of PACU.
Time frame: 5 hours
Ventilation inhomogeneity after the end of induction before the surgical procedure.
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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.
Alexander Fuchs, PD MD principal investigator
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic superimposed high frequency jet ventilation ventilation using the TwinStream EVO (Carl Reiner GmbH, Vienna, Austria) and High-flow nasal supplemental oxygen via nasal cannula with the Optiflow (Fisher & Paykel, Auckland, New Zealand) in people with Airway Managment and Laryngotracheal Surgery, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Fuchs, PD MD (+41 31 632 52 01, alexander.fuchs@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall number of cases without interruptions (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.