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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05243758
Other study ID # B.30.2.ODM.0.20.08/1822
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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