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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02478203
Other study ID # KOU KAEK 2014/108
Secondary ID
Status Completed
Phase N/A
First received April 17, 2015
Last updated February 2, 2017
Start date March 2015
Est. completion date July 2015

Study information

Verified date February 2017
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.


Description:

After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq , Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 2 Years to 7 Years
Eligibility Inclusion Criteria:

- pediatric

Exclusion Criteria:

- adult

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Airtraq
videolaryngoscope for difficult airway
Glidescope
videolaryngoscope for difficult airway
direct laryngoscopy
gold standart for intubation

Locations

Country Name City State
Turkey Kocaeli University School of Medicine Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary intubation time handling of the device till visualization of the tube entering through the vocal cords 120 seconds
Secondary need of maneuvers (mender applied or not) maneuver applied or not intraoperative
Secondary esophageal intubation (eosophageal intubation occured or not) eosophageal intubation occured or not intraoperative
Secondary intubation attempts (is it increased or not) the patient intubated at which attempt? intraoperative
Secondary cormack-lehane grade (which one improves the cormack- lehane grade) intraoperative
Secondary insertion time handling of the device till the glottic visualization 30 seconds
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