Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397261
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-04-29
Brief Title:
LarynGuide Assisted Tracheal Intubation
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Artificial Intelligence Assisted Tracheal Video Intubation an Observational Trial About Correctness of LarynGuide
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LarynGuide
Brief Summary:
This study aims to asses if the application of the larynGuide an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt
Detailed Description:
Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2 HR NIBP EtCO2
For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 10 and flow rates of 18Lmin until etO2 reaches 90 Induction of anesthesia and TI will be performed using a combination of sedativehypnotic drugs opioids and non-depolarizing muscle relaxant The following medications will be mandatory as per protocol
Hypnotic agent Propofol 1-4 mgkg
Opioids Fentanyl 1-3 mcgkg Remifentanyl 1-3 mcgkg
Non-depolarizing muscle relaxant Rocuronium 05-1 mgkg After induction of anesthesia and the administration of the muscle relaxant bag-mask ventilation with FiO2 10 flow rates of 18 Lmin-1 will be performed until apnea sets in After induction all patients will be paralyzed to facilitate airway management Neuromuscular blockade will be assessed by train-of-four monitoring Thereafter oxygen administration laryngoscopy and tracheal intubation are performed as usually
Tracheal intubation performed with the aid of larynGuide an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation aiEndoscopic Zürich Switzerland The larynGuide will be combined with the C-MAC video laryngoscope Karl Storz Tuttlingen Germany with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt The anaesthesiologist in charge board certified checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 Gold standard for detection of tube placement in anesthesia
For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words Bad intubation on the monitor and document either outcome
For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 10 and flow rates of 18Lmin until etO2 reaches 90 Induction of anesthesia and TI will be performed using a combination of sedativehypnotic drugs opioids and non-depolarizing muscle relaxant The following medications will be mandatory as per protocol
Hypnotic agent Propofol 1-4 mgkg
Opioids Fentanyl 1-3 mcgkg Remifentanyl 1-3 mcgkg
Non-depolarizing muscle relaxant Rocuronium 05-1 mgkg After induction of anesthesia and the administration of the muscle relaxant bag-mask ventilation with FiO2 10 flow rates of 18 Lmin-1 will be performed until apnea sets in After induction all patients will be paralyzed to facilitate airway management Neuromuscular blockade will be assessed by train-of-four monitoring Thereafter oxygen administration laryngoscopy and tracheal intubation are performed as usually
Tracheal intubation performed with the aid of larynGuide an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation aiEndoscopic Zürich Switzerland The larynGuide will be combined with the C-MAC video laryngoscope Karl Storz Tuttlingen Germany with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt The anaesthesiologist in charge board certified checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 Gold standard for detection of tube placement in anesthesia
For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words Bad intubation on the monitor and document either outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None