The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation Times
• Intervention / Treatment: Device: fiberoptic

Detailed Description

According to the inclusion and exclusion criteria，collecting the data of participants who undergone fiberoptic intubation. The observer analysis the safety and efficiency of fiberoptic intubation.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: qinye shi doctor, MD; Phone Number: 8618367915826; Email: 980276903@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1.American Society of Anesthesiologists 1~2

2.18-60 year

3.Adult patients requiring general anesthesia for orotracheal intubation

Exclusion Criteria:

1. Limited mouth opening
2. limited movement of temporomandibular joint
3. abnormal glottic anatomy
4. polyps of vocal cords

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3.8mm Group; Orotracheal intubation was performed with a 3.8 millimeter outer diameter fiberoptic	Device: fiberoptic; Tracheal intubation was performed with different outer diameters of fiberoptic.
2.8 mm group; Orotracheal intubation was performed with a 2.8 millimeter outer diameter fiberoptic	Device: fiberoptic; Tracheal intubation was performed with different outer diameters of fiberoptic.
4.8mm group; Orotracheal intubation was performed with a 4.8 millimeter outer diameter fiberoptic	Device: fiberoptic; Tracheal intubation was performed with different outer diameters of fiberoptic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hoarseness after surgery	Patients were asked about voice changes 24 hours after surgery	24 hours after surgery
Sore throat	Patients were asked about throat pain 24 hours after surgery	24 hours after surgery

Collaborators and Investigators

• Sponsor: Qinye Shi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Perioperative; Intubation; Sore throat; Success rate; Ffiberoptic
• Other Study ID Numbers: KY-2024-172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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