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Completed

NCT Number: NCT05243758

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University Faculty of Medicine

Samsun, Atakum, 55200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group video fiberscope of experienced practitioner

Device

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

Device

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

Device

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

Device

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)

Primary outcomes

  1. Intubation times,

    Time frame: during intubation

    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.

  2. Number of attempts

    Time frame: during intubation for patients,

    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.

  3. Time to find the glottis:

    Time frame: during intubation for patients

    The time from the moment the device entered between the patient's anterior incisors until the vocal cords were seen was recorded in seconds.

  4. Blood pressure

    Time frame: During intubation, at 1st, 2nd and 5th minutes after intubation

    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

  5. Pulse oximeter

    Time frame: Before induction (baseline), during intubation, at 1st, 2nd and 5th minutes after intubation

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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