- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06649526
Comparison of Two Different Video Laryngoscopes
Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34870
- University of Health Sciences Kartal Dr. Lütfi Kirdar City Hospital Cevizli D-100 Güney Yanyol, No:47 Kartal Istanbul Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time Frame: 3 months
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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
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Comparison of Direct and Indirect Images of Two Different Video Laryngoscopes in Adult Airway Management
Time Frame: 3 months
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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
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3 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sezen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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