NCT03118622

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

April 13, 2017

Last Update Submit

January 10, 2018

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    from laryngoscope pass incisors to end tidal CO2 appears

    less than 10 minute

Secondary Outcomes (1)

  • Intubation difficulty score

    less than 10 minute

Study Arms (2)

Pentax group

Intubation using Pentax

Device: Pentax

Macintosh group

Intubation using Macintosh

Interventions

PentaxDEVICE

Intubation using Pentax video laryngoscope in Pentax group

Pentax group

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients

You may qualify if:

  • ASA 1, 2
  • Scheduled surgery under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (1)

  • Yi IK, Kwak HJ, Kim KM, Ahn SH, Lee SY, Kim JY. Comparison of Pentax Airway Scope and Macintosh laryngoscope for orotracheal intubation in children: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2019 Aug;63(7):853-858. doi: 10.1111/aas.13368. Epub 2019 Mar 22.

    PMID: 30900242DERIVED

Study Officials

  • Jong Yeop Kim, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

May 31, 2017

Primary Completion

December 5, 2017

Study Completion

January 8, 2018

Last Updated

January 11, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)