NCT06649526

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 16, 2024

Last Update Submit

October 17, 2024

Conditions

Keywords

video laryngoscopyairway managementintubation

Outcome Measures

Primary Outcomes (2)

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

    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

    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

Study Arms (1)

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

Interventions

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.

Group MC McGrath videolaryngoscope Group H Hugmed Videolaryngoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, 34870, Turkey (Türkiye)

Location

Related Publications (1)

  • Sezen O, Simsek T, Simsek AK, Arslan G, Saracoglu KT, Saracoglu A. Comparison of direct and indirect images and hemodynamic response of two different video laryngoscopes to tracheal intubation. BMC Anesthesiol. 2025 Feb 20;25(1):86. doi: 10.1186/s12871-025-02966-7.

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

September 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations