SuprAglottic Jet Ventilation vs High-flow Nasal Oxygen in Tubeless Laryngotracheal Surgery
- Conditions
- Airway ManagmentLaryngotracheal Surgery
- Interventions
- 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)
- Registration Number
- NCT06609915
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- 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 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Written informed consent
- Patients aged ≥18 years
- Patients requiring elective tubeless laryngotracheal surgery
- Patients <18 years
- High risk of aspiration which concludes the consideration of using a tube in order to prevent aspiration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group supraglottic superimposed high frequency jet ventilation ventilation using the Monsoon 4 (Thora Tech GmbH, Giessen, Germany) 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 Control group 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
- Primary Outcome Measures
Name Time Method Overall number of cases without interruptions 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.
- Secondary Outcome Measures
Name Time Method Respiratory complications 24 hours 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).
End-expiratory lung impedance (EELI) after the end of induction before the surgical procedure. 1 hour End-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 hours End-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 hours End-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 hours End-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 hour Proportion 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 hours 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.
Changes in silent spaces at the end of the surgical procedure. 3 hours Proportion 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 hours 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).
Ventilation inhomogeneity after the end of anaesthesia. 3 hours Ventilation 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 hours Ventilation 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 hour Ventilation inhomogeneity detected by using electrical impedance tomography (EIT) after the end of induction before the surgical procedure.
Time until desaturation 2 hours Time until desaturation starting with laser surgery
Reason for change of airway strategy 5 minutes Reason for change of airway strategy given by the attending
Duration of interruptions 15 minutes Duration of surgical interruptions to permit rescue
Number of interruptions 5 minutes Number of surgical interruptions to permit rescue
Overall anesthesia time 3 hours Overall anesthesia time
Duration of desaturation 5 minutes Duration of desaturation (SpO2 \<80%)
Overall surgery time 2 hours Overall surgery time
Duration of hypercapnia 5 minutes Duration of hypercapnia (\>70mmHg)
Value of oxygen level 5 minutes Value of lowest recorded SpO2 in %
Value of carbon dioxide level 5 minutes Value of highest recorded tcCO2 in mmHg
Trial Locations
- Locations (2)
Inselspital
🇨🇭Bern, Switzerland
University Hospital Bern
🇨🇭Bern, Switzerland