Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System (MGEIAACRS)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot system intervention
  1. Evaluate the patient and sign the informed consent
  2. The patient was given general anesthesia
  3. Use magnetically guided tracheal intubation and airway cleaning robot system
  1. 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.
  2. 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.
  3. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of endotracheal intubation
Time Frame: measured at the time of the end of endotracheal intubation,up to 1 hour
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
Time Frame: measured at the time of the end of airway cleaning,up to 1 hour
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
Time Frame: measured at the time of the end of endotracheal intubation and airway cleaning robot system,up to 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yi Lv, MD, First Affiliated Hospital Xi'an Jiaotong University
  • Principal Investigator: Qiang Wang, MD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

August 5, 2020

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • XJTU1AF2015LSL-046-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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