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The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope

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ClinicalTrials.gov Identifier: NCT03962374
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.

Condition or disease Intervention/treatment Phase
Anesthesia, General Device: Frova Device: Stylet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Frova
Frova will be used to facilitate the endotracheal intubation.
Device: Frova
Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Active Comparator: Stylet
Stylet will be used to facilitate the endotracheal intubation.
Device: Stylet
Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.




Primary Outcome Measures :
  1. Success rate of first attempt of endotracheal intubation [ Time Frame: for 10 minutes during anesthetic induction ]
    The endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.


Secondary Outcome Measures :
  1. time for endotracheal intubation [ Time Frame: for 10 minutes during anesthetic induction ]
    Time will be measured from when the blades of the videolaryngoscope pass through the patient's mouth until the end-tidal CO2 is detected.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
  • 2. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.

Exclusion Criteria:

  • 1. Patients receiving emergency surgery
  • 2. Pregnant women
  • 3. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
  • 4. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
  • 5. Patients who are at risk of vomiting due to not fasting time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962374


Contacts
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Contact: Hyun Joo Kim, MD, Ph.D 02-2224-1389 jjollong@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Hyun Joo Kim, M.D., Ph.D.    82-2-2224-1389    JJOLLONG@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03962374     History of Changes
Other Study ID Numbers: 4-2019-0289
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs