Pentax Videolaryngoscopy in Children

Intubation;Difficult Clinical Trial

— Pentax  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118622
• Other study ID #: AJIRB-TEMP-TEMP-17-170
• Status: Completed
• Phase: N/A
• First received: April 13, 2017
• Last updated: January 10, 2018
• Start date: May 31, 2017
• Est. completion date: January 8, 2018

Study information

• Verified date: January 2018
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 8, 2018
• Est. primary completion date: December 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation;Difficult

Intervention

Device:
• Pentax
Intubation using Pentax video laryngoscope in Pentax group

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	from laryngoscope pass incisors to end tidal CO2 appears	less than 10 minute
Secondary	Intubation difficulty score	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	less than 10 minute