Comparison of Video Laryngoscopy With Rigid Stylet vs Video Laryngoscopy With the TCI Articulating Introducer for Endotracheal Intubation in Simulated Difficult Airways

NCT06115694 | Unknown

• 1 other identifier: GWang025
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose: To compare the efficacy and safety of TCI tube core and ordinary tube core assisted tracheal intubation in simulating difficult airway under visual laryngoscope, and to provide reference for clinical application

Conditions

Intubation; Difficult or Failed

Keywords

TCI Articulating Introducer; Endotracheal cannula; Simulated difficult airway

Outcome Measures

Primary Outcomes (1)

• The success of intubation for the first time

  To compare the success rate of first intubation in simulated difficult airway with TCI tube assisted by visual laryngoscope and ordinary tube.

  1 day of surgery

Secondary Outcomes (3)

• Overall success rate of intubation

  1 day of surgery

• Whether it is necessary to rotate the tracheal tube through the glottis

  1 day of surgery

• Throat complications

  24 hours after surgery

Study Arms (2)

Experimental group：TCI Articulating Introducer

ACTIVE COMPARATOR

Tracheal intubation was performed using a TCI core under a visual laryngoscope

Device: TCI Articulating Introducer

Control group：GlideRite® Rigid Stylet

PLACEBO COMPARATOR

Tracheal intubation was performed under a visual laryngoscope using a common tube core

Device: GlideRite® Rigid Stylet

Interventions

TCI Articulating Introducer DEVICE

use

Experimental group：TCI Articulating Introducer

GlideRite® Rigid Stylet DEVICE

use

Control group：GlideRite® Rigid Stylet

Eligibility Criteria

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

You may qualify if:

• Men ≥18 years of age or non-pregnant women;
• For elective gynecological surgery or upper abdominal surgery under general anesthesia by oral tracheal intubation, the operation position was supine and the operation time was less than 3 hours;
• Subject's American Society of Anesthesiologists physical status is I-III
• Subjects who could understand the purpose of the trial, voluntarily participated and signed the informed consent form, and were willing to accept the designated follow-up.

You may not qualify if:

• any cerebrovascular accident, such as stroke, transient ischemic attack (TIA), etc. occurred within 3 months;
• patients with unstable angina pectoris or myocardial infarction within 3 months;
• laryngeal mass, obstruction, maxillofacial fracture or deformity;
• Full stomach, high intra-abdominal pressure, habitual vomiting, gastroesophageal reflux disease;
• pharyngeal infection, hematoma, abscess, tonsil enlargement;
• Upper respiratory tract infection within one month, fever, cough, runny nose, nasal congestion, etc.;
• history of chronic airway inflammation, airway hyperresponsiveness or asthma;
• diabetic patients with severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.);
• severe complications of hypertension, such as arterial dissection, renal failure, cerebral hemorrhage, etc.;
• reoperation within 3 months;
• patients with contraindications or allergies to intraoperative drugs;
• patients enrolled in other studies within 30 days;
• poor adherence or the investigator's opinion that the patient was not suitable for the study.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Central Study Contacts

Wei Cui,MD

CONTACT

13821678013; cuwe2528@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share