Comparison of Two Different Video Laryngoscopes

October 17, 2024 updated by: Özlem Sezen, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management

The aim of this study is to answer the question of whether direct laryngoscopy can be performed with videolaryngoscopes. How do the videos of the laryngoscopes provide images directly in laryngoscopy? Primary objective: To compare the images of Hugemed and Mcgrath videolarinygoscope in direct laryngoscopy and indirect laryngoscopy secondary objective: to compare the effects on haemodynamic response Participants :people who are not expected to have difficult intubation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

Direct and indirect images of hugemed and McGrath videolaryngoscope during intubation, haemodynamic responses, procedure time will be compared

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 (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.
70

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
      • Istanbul, Turkey, 34870
        • University of Health Sciences Kartal Dr. Lütfi Kirdar City Hospital Cevizli D-100 Güney Yanyol, No:47 Kartal Istanbul Turkey

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

After Ethics Committee approval and written informed consent were obtained, the study will be conducted with 70 patients aged 18-65 years and older of both sexes with American Society of Anaesthesiologists (ASA) physical status I-III. Patients will be divided into two groups by closed envelope method.

McGrath video laryngoscope (MG) will be used in patients in group MC; Modified Cormack Lehane score and POGO score in direct laryngoscopic images and Modified Cormack Lehane score and POGO score in indirect laryngoscopic images of the patients will be evaluated and recorded and then orotracheal intubation will be performed.

Hugemed videolaryngoscope (HG) will be used in patients in group H and orotracheal intubation will be performed after the Modified Cormack Lehane scores and POGO scores obtained from direct laryngoscopic and indirect laryngoscopic images of the patients are recorded.

Description

Inclusion Criteria:

To be between 18 -65 years old Mallampati score I-II Cormack-Lehane score I-II ASA physical status I-II who required endotracheal intubation for elective surgery

Exclusion criteria Pregnancy Mallampati score III-IV Cormack-Lehane score III-IV ASA physical score III-IV sternomental distance < 12.5 cm mandibular-hyoid distance < 6 cm

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.
Group MC McGrath videolaryngoscope Group H Hugmed Videolaryngoscope

All patients will receive intravenous premedication with midazolam 0.03 mg/kg approximately 30 minutes before induction of anaesthesia. Preoperatively, standard monitoring included a 3-lead electrocardiogram (ECG) with continuous ST-segment analysis and assessment of peripheral oxygen saturation (SpO2) and intermittent non-invasive blood pressure. Following preoxygenation with 100% oxygen for three minutes, general anaesthesia would be induced with propofol (3mg/kg) a few minutes after injection of fentanyl (2µg/kg). Neuromuscular paralysis will be induced with rocuronium (0.5 mg/kg) in all patients.In group MC, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with McGrath videolaryngoscope.

In Group H, direct and indirect Modified Cormack Lehane score and POGO score will be evaluated with Hugemed videolaryngoscope.
Other: endotracheal intubation with videolaryngoscope
The present study will compare the images of two different VLs with Macintosh blades (the McGrath videolaryngoscope and the Hugemed videolaryngoscope) in both indirect (screen images) and direct (images viewed through the mouth) laryngoscopy.

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
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time Frame: 3 months

Videolaryngoscopy (VL) is a frequently used method in airway management to improve the success of tracheal intubation in recent years. VLs have a miniature video camera at the tip of the blades which allows indirect visualisation of the glottis (1,2,3).

The American Society of Anaesthesiologists (ASA) recommends that a VL should be available and used for all patients with a particularly difficult airway and for whom intubation is planned In recent years, a number of VLs have emerged that offer several advantages over direct laryngoscopy.It is aimed to compare direct and indirect images of mcgrath and hugemed videolaryngoscope.
3 months
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time Frame: 3 months
The principal objective of this study was to undertake a comparative analysis of the images produced by two distinct VLs during direct and indirect laryngoscopy
3 months

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.
Dr. Lutfi Kirdar Kartal Training and Research Hospital

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.
September 1, 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.
November 1, 2024

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.
November 1, 2024

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).
October 16, 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.
October 17, 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.
October 18, 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.
October 18, 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.
October 17, 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.
October 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.
  • Sezen

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.

Clinical Trials on Anesthesia

Clinical Trials on endotracheal intubation with videolaryngoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings