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

Intubation; Difficult or Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243758
• Other study ID #: B.30.2.ODM.0.20.08/1822
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: November 2018
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Responsiveness
• Intubation; Difficult or Failed

Intervention

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.
• 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.
• 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.
• 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)

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University Faculty of Medicine	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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,
Primary	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
Primary	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
Primary	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