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Completed

NCT Number: NCT03118622

Pentax Videolaryngoscopy in Children

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

Completed

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Key information

Conditions

Intubation;Difficult

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentax

Device

Intubation using Pentax video laryngoscope in Pentax group

Primary outcomes

  1. Intubation time

    Time frame: less than 10 minute

    from laryngoscope pass incisors to end tidal CO2 appears

Secondary outcomes

  1. Intubation difficulty score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Acronym: Pentax

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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