NCT06709118

Brief Summary

Fiberoptic intubation is an important method for anesthesiologists to deal with difficult airways, but its operation is difficult and requires repeated practice. Fiberoptic intubation is performed in two steps. First, the anesthesiologist holds the bronchoscope and exposes the base of the tongue, the epiglottis, and the glottis successively according to the front camera of the bronchoscope. Through the glottis, the main trachea is exposed to the carina. This process is visual and the anesthesiologist can see the main tissue structure directly. Then, the endotracheal catheter enters the endotracheal along the bronchoscope, and the process of endotracheal catheter entry is not visual. In clinical work, it was found that the tracheal catheter was easily blocked when it passed through the glottis, and it was necessary to adjust the position of the tracheal catheter for several times before the tracheal catheter could be sent into the tracheal tube, which was easy to cause throat injury in the process. At present, relevant studies are mainly focused on the first step of bronchoscopic intubation, how to quickly expose the glottis and complete the bronchoscopic guidance process. However, there is no clear mention of the situation of catatoning in the process of endotracheal catheter and how to solve the problem of catatoning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 25, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

IntubationFfiberopticPerioperativeSore throatSuccess rate

Outcome Measures

Primary Outcomes (4)

  • Fiberoptic intubation attempts

    This is used to observe the passage of the tracheal tube through the glottis

    during the procedure

  • First intubation success rate

    The incidence of tracheal tube through the vocal cords

    during the procedure

  • Fiberoptic intubation time

    The duration of the intubation process

    during the procedure

  • Time of passage of tracheal intubation through glottis

    The time the tracheal tube enters the trachea

    during the procedure

Secondary Outcomes (2)

  • Hoarseness after surgery

    24 hours after surgery

  • Sore throat

    24 hours after surgery

Study Arms (3)

3.8mm Group

Orotracheal intubation was performed with a 3.8 millimeter outer diameter fiberoptic

Device: fiberoptic

2.8 mm group

Orotracheal intubation was performed with a 2.8 millimeter outer diameter fiberoptic

Device: fiberoptic

4.8mm group

Orotracheal intubation was performed with a 4.8 millimeter outer diameter fiberoptic

Device: fiberoptic

Interventions

Tracheal intubation was performed with different outer diameters of fiberoptic.

2.8 mm group3.8mm Group4.8mm group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients in need of oral tube intubation and general anesthesia in our hospital for elective surgery

You may qualify if:

  • American Society of Anesthesiologists 1\~2
  • year
  • Adult patients requiring general anesthesia for orotracheal intubation

You may not qualify if:

  • Limited mouth opening
  • limited movement of temporomandibular joint
  • abnormal glottic anatomy
  • polyps of vocal cords

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Piegeler T, Clausen NG, Weiss M. Effectiveness of tip rotation in fibreoptic bronchoscopy under different experimental conditions: an in vitro crossover study. Br J Anaesth. 2017 Dec 1;119(6):1206-1212. doi: 10.1093/bja/aex322.

    PMID: 29028928BACKGROUND
  • Karmali S, Rose P. Tracheal tube size in adults undergoing elective surgery - a narrative review. Anaesthesia. 2020 Nov;75(11):1529-1539. doi: 10.1111/anae.15041. Epub 2020 May 16.

    PMID: 32415788BACKGROUND
  • Teulieres M, Berard E, Marot V, Reina N, Ferre F, Minville V, Cavaignac E. A quadruple peripheral nerve block outside the OR for anterior cruciate ligament reconstruction reduces the OR occupancy time. Knee Surg Sports Traumatol Arthrosc. 2023 Jul;31(7):2917-2926. doi: 10.1007/s00167-022-07246-2. Epub 2022 Dec 5.

    PMID: 36469051BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Optical Fibers

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and Supplies

Central Study Contacts

qinye shi doctor, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Fourth Affiliated Hospital of Zhejiang University Medical College

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 29, 2024

Study Start

December 10, 2024

Primary Completion

May 31, 2025

Study Completion

October 31, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share