Who is Rapid And Success? The Comparison Of Video Fiberscope And Video Laryngoscope

February 7, 2022 updated by: Halil CEBECI, Ondokuz Mayıs University

The Comparison Of Video Fiberscope And Video Laryngoscope,With Egri Score> 4

Endotracheal intubation plays an important role in general anesthesia. Complications can be prevented by using alternative airway devices in predetermined difficult intubation cases. In this study, the investigators aimed to compare the results of endotracheal intubation with video fiberscope and DCI video laryngoscope devices of two different experienced physicians (E and H).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

In this randomized and prospective study, 60 patients with EGRI score> 4 and ASA score <4, operated between 1 October 2018 and 1 March 2019 in Ondokuz Mayıs University Medical Faculty Hospital were included. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.

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.
Interventional

Enrollment (Actual)

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.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55200
        • Ondokuz Mayis University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Operated in the operating room of our hospital,
  • Aged 18-65,
  • EGRI score>4,
  • ASA (American Society of Anesthesiologists) score<4

Exclusion Criteria:

  • Cerebrovascular disease (cerebral ischemia, hemorrhage or stroke), presence of carotid stenosis or history of coronary artery disease,

    • Neurological disorders (history of chronic headache, epilepsy or head trauma), alcohol or psychoactive drug addiction,
    • Serious heart and/or lung diseases, liver and/or kidney failure,
    • Uncontrolled diabetes and/or hypertension,
    • Dental abscess,
    • Mouth opening <1.5 cm,
    • Known bleeding disorder,
    • Pregnancy,
    • Mental retardation,
    • Contraindications to drugs, allergy to drugs used,
    • Patient rejection

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Group video fiberscope of experienced practitioner
More experienced physician: endotracheal intubation with video fiberscope Assoc. Dr. The group in which Ersin Köksal performed endotracheal intubation using a video fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
Device: Group video fiberscope of experienced practitioner
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopyvideo fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Device: Group video fiberscope of less experienced practitioner
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopy video fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Active Comparator: Group video laryngoscope of experienced practitioner
More experienced physician: Endotracheal intubation with DCI video laryngoscopeThe group in which Assoc. Dr. Ersin Köksal performed endotracheal intubation using a DCI video laryngoscope(Storz DCI Video Laryngoscope (Karl Storz GmbH &Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
Device: Group video laryngoscope of experienced practitioner
Intubation Pending Difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.
Device: Group video laryngoscope of less experienced practitioner
Entubation pending difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.Storz DCI Video Laryngoscope (Karl Storz GmbH &Co. KG, Tuttlingen, Germany)
Active Comparator: Group video fiberscope of less experienced practitioner
Endotracheal intubation with video fiberscope: The group in which DrHalil Cebeci applied endotracheal intubation using a video fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany) consisted of 15 patients. Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
Device: Group video fiberscope of experienced practitioner
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopyvideo fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Device: Group video fiberscope of less experienced practitioner
One of the classical alternatives to laryngoscopy in difficult endotracheal intubation is video laryngoscopy video fiberscope( Karl Storz GmbH &Co. KG, Tuttlingen, Germany). Reaching the image from the patient with pre- and from the cervical point of view, or from the cervical point of view, to be completed with a good view from a large screen to be completed with an image before and within intubation. It also facilitates learning in education.
Active Comparator: Group video laryngoscope of less experienced practitioner
Endotracheal intubation with DCI video laryngoscope:The group in which Dr.Halil Cebeci applied endotracheal intubation using a DCI video laryngoscope(Karl Storz GmbH &Co. KG, Tuttlingen, Germany) consisted of 15 patients.Endotracheal intubation was performed by two practitioners using two different devices. Intubation times, number of attempts, failed attempts, postoperative complications and hemodynamic responses were recorded.
Device: Group video laryngoscope of experienced practitioner
Intubation Pending Difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.
Device: Group video laryngoscope of less experienced practitioner
Entubation pending difficult as well as challenging . Fiberoptic (fiberscope) intubation is the gold standard in difficult airway. Lacking this supplement, it will be widely used for practice, as it is suitable for video laryngeal.Storz DCI Video Laryngoscope (Karl Storz GmbH &Co. KG, Tuttlingen, Germany)

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
Intubation times,
Time Frame: during intubation
The moment when the endotracheal intubation tube was passed between the vocal cords following the vocal cord image obtained with the device was recorded in seconds. In endotracheal intubation performed with a video fiberscope, the end of the fiberscope with a camera passing through the vocal cords, and in endotracheal intubation performed with a DCI video laryngoscope, the intubation tube passing between the vocal cords was counted as successful intubation time.
during intubation
Number of attempts
Time Frame: during intubation for patients,
The procedure will be considered unsuccessful if intubation is unsuccessful in three attempts, if the intubation process exceeds three minutes, or if the peripheral oxygen saturation (SpO2) is <90% during this period. If this situation was encountered, it was planned to ventilate the patient with an anesthesia mask until the oxygen saturation approached 100% and to use alternative airway devices.
during intubation for patients,
Time to find the glottis:
Time Frame: during intubation for patients
The time from the moment the device entered between the patient's anterior incisors until the vocal cords were seen was recorded in seconds.
during intubation for patients
Blood pressure
Time Frame: During intubation, at 1st, 2nd and 5th minutes after intubation
Hemodynamic parameters; heart rate (/min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), and SpO2 were recorded before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
During intubation, at 1st, 2nd and 5th minutes after intubation
Pulse oximeter
Time Frame: Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation
Oximetry is a convenient and painless alternative to needlesticks, is simple to use, and provides immediate data. These advantages make oximetry an invaluable tool for determination the client's need for oxygen therapy and assessing effectiveness of therapy. The oximeter registers arterial oxygen saturation (SaO2). An SaO2 greater than 95% is considered normal, whereas values lower than 93% usually indicate the need for oxygen therapy and further assessment.
Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation

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.
Ondokuz Mayıs University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ERSIN KOKSAL, PROFFOSOR, Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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.
November 1, 2018

Primary Completion (Actual)

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.
March 1, 2019

Study Completion (Actual)

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.
March 1, 2019

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).
December 5, 2021

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.
February 7, 2022

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.
February 17, 2022

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.
February 17, 2022

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.
February 7, 2022

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, 2018

More Information

Terms related to this study

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.
  • B.30.2.ODM.0.20.08/1822

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

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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