Pentax Videolaryngoscopy in Children

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03118622

Collaborator

(none)

136

Enrollment

Location

7.3

Actual Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Device: Pentax

Detailed Description

Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope.

In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.

Study Design

Study Type:

Observational

Actual Enrollment :

136 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

A Comparison of Pentax AWS Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children: a Randomized Controlled Trial

Actual Study Start Date :

May 31, 2017

Actual Primary Completion Date :

Dec 5, 2017

Actual Study Completion Date :

Jan 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Pentax group Intubation using Pentax	Device: Pentax Intubation using Pentax video laryngoscope in Pentax group
Macintosh group Intubation using Macintosh

Arm

Intervention/Treatment

Pentax group

Intubation using Pentax

Device: Pentax

Intubation using Pentax video laryngoscope in Pentax group

Macintosh group

Intubation using Macintosh

Outcome Measures

Primary Outcome Measures

Intubation time [less than 10 minute]
from laryngoscope pass incisors to end tidal CO2 appears

Secondary Outcome Measures

Intubation difficulty score [less than 10 minute]
IDS parameter is Number of attempts > 1 = N1 Number of operators >1 = N2 Number of alternative techniques = N3 Cormack and Lehane grade minus 1 = N4 Operator perception of lifting force required Normal N5 = 0 Greater than in routine practice N5=1 Laryngeal pressure applied Not applied N6=0 Applied N6=1 Vocal core mobility Abduction N7=0 Adduction &/or impending tube passage N7=1 Total IDS = sum of scores N1~N7

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA 1, 2
Scheduled surgery under general anesthesia

Exclusion Criteria:

Intraoral disease
Congenital anomaly
C-spine injury
Patients who need Rapid sequence induction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou university school of medicine	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

Principal Investigator: Jong Yeop Kim, MD, Ajou University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-kyong Yi, Clinical assistant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT03118622

Other Study ID Numbers:

AJIRB-TEMP-TEMP-17-170

First Posted:

Apr 18, 2017

Last Update Posted:

Jan 11, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 11, 2018