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Pentax Videolaryngoscopy in Children (Pentax)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118622
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
In-kyong Yi, Ajou University School of Medicine

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

Condition or disease Intervention/treatment
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.

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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 : December 5, 2017
Actual Study Completion Date : January 8, 2018

Group/Cohort Intervention/treatment
Pentax group
Intubation using Pentax
Device: Pentax
Intubation using Pentax video laryngoscope in Pentax group

Macintosh group
Intubation using Macintosh



Primary Outcome Measures :
  1. Intubation time [ Time Frame: less than 10 minute ]
    from laryngoscope pass incisors to end tidal CO2 appears


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118622


Locations
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Korea, Republic of
Ajou university school of medicine
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Jong Yeop Kim, MD Ajou University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: April 18, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No