The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope
Sponsor
Yonsei University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03962374
Collaborator
(none)
188
1
2
23
8.2
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date
:
Jul 1, 2019
Anticipated Primary Completion Date
:
May 1, 2021
Anticipated Study Completion Date
:
Jun 1, 2021
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Success rate of first attempt of endotracheal intubation [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
- time for endotracheal intubation [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
-
- 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:
-
- Patients receiving emergency surgery
-
- Pregnant women
-
- Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
-
- 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
-
- Patients who are at risk of vomiting due to not fasting time
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | Korea, Republic of | 03722 |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT03962374
Other Study ID Numbers:
- 4-2019-0289
First Posted:
May 24, 2019
Last Update Posted:
May 24, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No