Clinical trial NCT04327076: Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System
Official title: Clinical Application of Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: General Anesthesia
Keywords: Endotracheal intubation
Airway cleaning
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients about to undergo general anesthesia.
2. Age \>18 years.
3. Informed consent obtained.
4. Generally in good condition before operation.

Exclusion Criteria:

1. Patients are unwilling to this procedure.
2. Patients with Patient has maxillofacial mass, oropharyngeal mass, neck mass.
3. Patients with loose teeth.

Primary outcomes:
measure: success rate of endotracheal intubation
timeFrame: measured at the time of the end of endotracheal intubation，up to 1 hour
measure: success rate of airway cleaning
timeFrame: measured at the time of the end of airway cleaning，up to 1 hour
Secondary outcomes:
measure: complications of endotracheal intubation and airway cleaning robot system
timeFrame: measured at the time of the end of endotracheal intubation and airway cleaning robot system,up to 1 week
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yi Lv, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Qiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
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