Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609915
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
SuprAglottic superImposed High Frequency Jet Ventilation veRsus High-flow nAsal oxYgen in Tubeless Laryngotracheal Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIRWAY
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 10 until etO2 reaches 09 The induction of anesthesia will be performed using a combination of sedativehypnotic drugs opioids and muscle relaxant
The following medications will be mandatory as per protocol
A neuromuscular blocking agent NMBA Rocuronium 05-1 mgkg
Propofol 1-3 mgkg
Opioid Fentanyl 1-3mcgkg Remifentanyl 1-3mcgkg
After induction of anesthesia and the administration of a NMBA bag-mask ventilation with FiO2 10 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 10 FiO2 will be reduced to 03 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 Lmin FiO2 10 via nasal cannula with the Optiflow Fisher Paykel Healthcare Auckland New Zealand FiO2 will remain at 10 FiO2 will be reduced to 03 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 participants 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 13 The device is suitable for assessment of jet ventilation and high flow 14
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 USA15-17
Induction of anesthesia Patients will be preoxygenated before induction of anesthesia for at least one minute through face-mask with FiO2 10 until etO2 reaches 09 The induction of anesthesia will be performed using a combination of sedativehypnotic drugs opioids and muscle relaxant
The following medications will be mandatory as per protocol
A neuromuscular blocking agent NMBA Rocuronium 05-1 mgkg
Propofol 1-3 mgkg
Opioid Fentanyl 1-3mcgkg Remifentanyl 1-3mcgkg
After induction of anesthesia and the administration of a NMBA bag-mask ventilation with FiO2 10 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 10 FiO2 will be reduced to 03 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 Lmin FiO2 10 via nasal cannula with the Optiflow Fisher Paykel Healthcare Auckland New Zealand FiO2 will remain at 10 FiO2 will be reduced to 03 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 participants 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 13 The device is suitable for assessment of jet ventilation and high flow 14
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 USA15-17
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None