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

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: Completed
• Conditions: Intubation; Difficult or Failed; Airway Responsiveness
• Intervention / Treatment: Device: Group video fiberscope of experienced practitioner; Device: Group video fiberscope of less experienced practitioner; Device: Group video laryngoscope of experienced practitioner; Device: Group video laryngoscope of less experienced practitioner

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Intubation times,	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	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:	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	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	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

• Sponsor: Ondokuz Mayıs University
• Investigators: Study Director: ERSIN KOKSAL, PROFFOSOR, Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: December 5, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID 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