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

NCT05243758 | Completed DMC

• 1 other identifier: B.30.2.ODM.0.20.08/1822
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intubation; Difficult or Failed; Airway Responsiveness

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

Group video fiberscope of experienced practitioner

ACTIVE COMPARATOR

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; Device: Group video fiberscope of less experienced practitioner

Group video laryngoscope of experienced practitioner

ACTIVE COMPARATOR

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; Device: Group video laryngoscope of less experienced practitioner

Group video fiberscope of less experienced practitioner

ACTIVE COMPARATOR

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; Device: Group video fiberscope of less experienced practitioner

Group video laryngoscope of less experienced practitioner

ACTIVE COMPARATOR

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; Device: Group video laryngoscope of less experienced practitioner

Interventions

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 fiberscope of experienced practitioner; Group video fiberscope of less experienced practitioner

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 laryngoscope of experienced practitioner; Group video laryngoscope of less experienced practitioner

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 fiberscope of experienced practitioner; Group video fiberscope of less experienced practitioner

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)

Group video laryngoscope of experienced practitioner; Group video laryngoscope of less experienced practitioner

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Operated in the operating room of our hospital,
• Aged 18-65,
• EGRI score\>4,
• ASA (American Society of Anesthesiologists) score\<4

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University Faculty of Medicine

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Study Officials

• ERSIN KOKSAL, PROFFOSOR

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident ,Principal Investigator

Model Details: 60 patients aged between 18-65 years, who were operated in the operating room of our hospital, with an EGRI score of \>4 and an ASA (American Society of Anesthesiologists) score of \<4 were included.

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: February 17, 2022
• Study Start: November 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: February 17, 2022

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)