Magnetically Guided Endotracheal Intubation and Airway Cleaning Robot System

NCT04327076 | Unknown

• 1 other identifier: XJTU1AF2015LSL-046-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

Endotracheal intubation; Airway cleaning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• complications of endotracheal intubation and airway cleaning robot system

  measured at the time of the end of endotracheal intubation and airway cleaning robot system,up to 1 week

Study Arms (1)

Robot system intervention

EXPERIMENTAL

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

Device: Using robot system of endotracheal intubation and airway cleaning

Interventions

Using robot system of endotracheal intubation and airway cleaning DEVICE

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.

Robot system intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (11)

• Mwakanyanga ET, Masika GM, Tarimo EAM. Intensive care nurses' knowledge and practice on endotracheal suctioning of the intubated patient: A quantitative cross-sectional observational study. PLoS One. 2018 Aug 16;13(8):e0201743. doi: 10.1371/journal.pone.0201743. eCollection 2018.

  PMID: 30114257 BACKGROUND

• Stewart MG. Classics from The Laryngoscope: Celebrating 120 years of impact. Laryngoscope. 2015 Oct;125(10):2237. doi: 10.1002/lary.25271. Epub 2015 Sep 5. No abstract available.

  PMID: 26341863 BACKGROUND

• Xu Z, Ma W, Hester DL, Jiang Y. Anticipated and unanticipated difficult airway management. Curr Opin Anaesthesiol. 2018 Feb;31(1):96-103. doi: 10.1097/ACO.0000000000000540.

  PMID: 29176376 BACKGROUND

• Hsu HT, Chou SH, Wu PJ, Tseng KY, Kuo YW, Chou CY, Cheng KI. Comparison of the GlideScope(R) videolaryngoscope and the Macintosh laryngoscope for double-lumen tube intubation. Anaesthesia. 2012 Apr;67(4):411-5. doi: 10.1111/j.1365-2044.2011.07049.x. Epub 2012 Feb 11.

  PMID: 22324297 BACKGROUND

• Collins SR, Blank RS. Fiberoptic intubation: an overview and update. Respir Care. 2014 Jun;59(6):865-78; discussion 878-80. doi: 10.4187/respcare.03012.

  PMID: 24891196 BACKGROUND

• Moore A, Schricker T. Awake videolaryngoscopy versus fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2019 Dec;32(6):764-768. doi: 10.1097/ACO.0000000000000771.

  PMID: 31356364 BACKGROUND

• Tighe PJ, Badiyan SJ, Luria I, Lampotang S, Parekattil S. Robot-assisted airway support: a simulated case. Anesth Analg. 2010 Oct;111(4):929-31. doi: 10.1213/ANE.0b013e3181ef73ec.

  PMID: 20870983 BACKGROUND

• Hemmerling TM, Wehbe M, Zaouter C, Taddei R, Morse J. The Kepler intubation system. Anesth Analg. 2012 Mar;114(3):590-4. doi: 10.1213/ANE.0b013e3182410cbf. Epub 2011 Dec 20.

  PMID: 22190550 BACKGROUND

• Hemmerling TM, Taddei R, Wehbe M, Zaouter C, Cyr S, Morse J. First robotic tracheal intubations in humans using the Kepler intubation system. Br J Anaesth. 2012 Jun;108(6):1011-6. doi: 10.1093/bja/aes034. Epub 2012 Mar 28.

  PMID: 22457483 BACKGROUND

• Favretto DO, Silveira RC, Canini SR, Garbin LM, Martins FT, Dalri MC. Endotracheal suction in intubated critically ill adult patients undergoing mechanical ventilation: a systematic review. Rev Lat Am Enfermagem. 2012 Sep-Oct;20(5):997-1007. doi: 10.1590/s0104-11692012000500023. English, Portuguese, Spanish.

  PMID: 23174846 BACKGROUND

• Haghighat S, Yazdannik A. The practice of intensive care nurses using the closed suctioning system: An observational study. Iran J Nurs Midwifery Res. 2015 Sep-Oct;20(5):619-25. doi: 10.4103/1735-9066.164509.

  PMID: 26457102 BACKGROUND

Study Officials

• Yi Lv, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Qiang Wang, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Feng, MD

CONTACT

0086-17749083602; 624779797@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: August 1, 2020
• Primary Completion: August 5, 2020
• Study Completion: December 30, 2023
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

CN (1)