The Effect of Different Fiberoptic Outer Diameters on Fiberoptic Intubation

November 27, 2024 updated by: Qinye Shi

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: qinye shi doctor, MD
  • Phone Number: 8618367915826
  • Email: 980276903@qq.com

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fiberoptic intubation attempts
Time Frame: during the procedure
This is used to observe the passage of the tracheal tube through the glottis
during the procedure
First intubation success rate
Time Frame: during the procedure
The incidence of tracheal tube through the vocal cords
during the procedure
Fiberoptic intubation time
Time Frame: during the procedure
The duration of the intubation process
during the procedure
Time of passage of tracheal intubation through glottis
Time Frame: during the procedure
The time the tracheal tube enters the trachea
during the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hoarseness after surgery
Time Frame: 24 hours after surgery
Patients were asked about voice changes 24 hours after surgery
24 hours after surgery
Sore throat
Time Frame: 24 hours after surgery
Patients were asked about throat pain 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qinye Shi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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