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

ConditionsAirway ManagmentLaryngotracheal Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Patients aged ≥18 years

Patients requiring elective tubeless laryngotracheal surgery

Disqualifiers

Patients <18 years

High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 hours

Secondary outcomes

1

Time until desaturation

Time until desaturation starting with laser surgery

Time frame
2 hours
2

Reason for change of airway strategy

Reason for change of airway strategy given by the attending

Time frame
5 minutes
3

Duration of interruptions

Duration of surgical interruptions to permit rescue

Time frame
15 minutes
4

Number of interruptions

Number of surgical interruptions to permit rescue

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: