Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System

Study Overview
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Brief Summary
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Endotracheal intubation refers to the use of special equipment, through the nasal cavity or oral cavity, through the throat, glottis, the process of inserting the endotracheal tube into the trachea or bronchus. Its main function is to maintain respiratory tract patency, positive pressure ventilation and removal of respiratory secretions. Endotracheal intubation and sputum suction are important parts of first aid and surgical anesthesia. Our team developed a magnetic navigation tracheal intubation and airway cleaning robot system to achieve mechanization and integration of surgical anesthesia, airway management. This study is designed to investigate the safety and efficacy of the Magnetic navigation tracheal intubation and airway cleaning robot.

Detailed Description
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Endotracheal intubation is a highly professional technique, especially for emergency patients with shallow coma, closed teeth and awake, it is more difficult to intubate. If the operation is improper, it is easy to damage the wound, pharynx and teeth or stimulate the throat to produce choking, breath holding, laryngospasm, aggravating hypoxia and mucosal injury. At present, the data of endotracheal intubation show that even under the non-emergency state of routine operation, the success rate of the first endotracheal intubation is 70%, and the success rate of secondary intubation is 89%. Under the pre-hospital emergency, the success rate of first intubation of ambulancemen is less than 50%, which is much lower than that of professional physicians. Therefore, it is of great significance to simplify the labor intensity of anesthesiologists and improve the intelligence of clinical operation. In this study, the electromagnetic acousto-optic fusion navigation technology is used to make a half-helmet type multi-axis magnetic coupling driving navigation robot cover on the left side of the patient's head in the supine position, automatically feeding the guide core with the internal magnetic tip through the external guide tube and intubating the trachea to the pharynx, applying the attraction of the external magnet to the neck hyoid so that the magnetic tip of the guide core in the endotracheal intubation points to the glottis. With the help of internal and external magnetic attraction and moderate driving force to push the guide core into the tube first, electromagnetic induction detection and spot image analysis determine it, continue to use the magnetic coupling device to push the guide bar to the bifurcation protuberance of the trachea, fix the guide bar, push the trachea intubation to the appropriate position, and then exit the guide bar and inflate the balloon. Sputum suction robot that can perform the sputum suction of a nurse simply, safely and effectively. It can be equipped with a closed sputum suction tube commonly used in clinical practice for sputum suction. And through a wired connection, the operator can perform sputum suction through the control unit at a long distance. In order to ensure that the machine is suitable for different patients and to ensure the safety of use, our equipment can set different depths of tube inlet, tube inlet speed, tube withdrawal speed, and sputum suction mode, while the sputum suction robot performs the entire process of sputum suction In this case, there is no need to stop the oxygen supply to the patient, and the risk of iatrogenic damage to the patient by hypoxia is also reduced To realize the mechanization and integration of surgical anesthesia and airway management.

Official Title
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Clinical Application of Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: Using robot system of endotracheal intubation and airway cleaning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients about to undergo general anesthesia. Age >18 years. Informed consent obtained. Generally in good condition before operation. Exclusion Criteria: Patients are unwilling to this procedure. Patients with Patient has maxillofacial mass, oropharyngeal mass, neck mass. Patients with loose teeth.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot system intervention<br>Evaluate the patient and sign the informed consent The patient was given general anesthesia Use magnetically guided tracheal intubation and airway cleaning robot system | Device: Using robot system of endotracheal intubation and airway cleaning<br>* Using the control screen to control the machine, the device first extends the intubation guide rail to the mouth of the patient's oropharyngeal ventilation tube, first sends the magnetic guide strip into the epigarynx, and at the same time, extends the magnetic anchoring unit to the patient's neck. The external magnetic anchoring unit can sense and attract the magnet on the magnetic guide strip. At this point, the machine can send the guide strip into the respiratory tract. Then, the control machine sends the tracheal intubation into the airway along the guide strip, and completes the balloon inflation to complete the endotracheal intubation operation. During or after the operation, when the sputum suction operation is needed, the parameters of the sputum suction machine are set on the operation screen to start the sputum suction operation, and the suction robot completes the sputum suction operation automatically.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of endotracheal intubation | Success rate of single endotracheal intubation by using robot system | measured at the time of the end of endotracheal intubation，up to 1 hour | 
| success rate of airway cleaning | The success rate of airway cleaning by using robot system | measured at the time of the end of airway cleaning，up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of endotracheal intubation and airway cleaning robot system | the complications of endotracheal intubation and airway cleaning robot system,including mistakenly inserted into the esophagus,teeth loose or fall out,Laryngeal edema,respiratory cardiac arrest,poorly ventilated,atelectasis,Tracheoesophageal fistula,tracheal mucosal injury,bleeding,etc. | measured at the time of the end of endotracheal intubation and airway cleaning robot system,up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal intubation, Airway cleaning