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Tongue Root Retractor For Fibroscopic Intubation

Effects of Tongue Root Retractor for Fibroscopic Intubation: a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04343014
Acronym
TRFI
Enrollment
300
Registered
2020-04-13
Start date
2016-03-10
Completion date
2020-12-10
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management

Keywords

fibreoptic intubation

Brief summary

Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical University and requiring endotracheal intubation for general anesthesia will be enrolled in this case controlled study. Patients 1) aged 18 to 70 years; 2) ASA graded I\ II class; 3) general anesthesia should be performed under endotracheal intubation, will be included from this study. Patients 1) with organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study. The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each patient position. Secondary outcomes include times to view the vocal cord and carina, the time for tube advancement through the vocal cords, as well as the total time to achieve tracheal intubation.Two anesthesiologists with 5 years of experience in conventional endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.

Interventions

DEVICETongue Root Retractor

Fibroptic endutracheal intubation will be performed with tongue root retractor.

DEVICEConventional Fibroscope

Fibroptic endutracheal intubation will be performed in conventional way.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* aged 18 to 70 years * ASA graded I\ II class * scheduled for elective surgery requiring orotracheal intubation

Exclusion criteria

* with organ transplant operations * with thoracic and cardiac vascular surgery * with severe cadiac or pulmonary disease * BMI over 35kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of intubation.From start of intubation to successfully intubated (the endotracheal tube enters the trachea and the cuff is inflated), usually within 3 minutes.Successs of intubation at different attempts.

Secondary

MeasureTime frameDescription
Epiglottis levelwithin 30 seconds after the beginning of fibroscopyAirway clearance at the epiglottis level was assessed by observing whether the epiglottis was in contact with the posterior pharyngeal wall
Carina timewithin 90 secondstime from the beginning of fibroscopy to the confirmation of the carina
Successful Intubation on 1st Attempfrom start of first intubation to end of first intubation attemptthe success rate on 1st attempt
Number of attempts for tube advancementwithin 120 secondsnumber of attempts for tube advancement from the beginning of fibroscopy to the success of the intubation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026