NCT03960567

Brief Summary

A classification method describing the larynx appearance during laryngoscopy accepted by all anesthetists has not been defined yet. In one study, it was shown that anesthetists mis classed the glottis image by 50%. The most commonly used classification method is the Cormack Lehane (CL) classification. This classification classifies the larynx appearance during direct laryngoscopy form 1 to 4. The modified CL classification is criticized as it does not predict difficult intubation and especially grade 2 is operator dependent and partial view is not well defined. The numerical expression of the percentage of the glottic aperture (POGO = percentile of glottic opening) is another score. In this score, A POGO score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening. The use of a standard and effective classification method will facilitate and accelerate communication between anesthetists in difficult life-threatening situations such as difficult airway / difficult intubation / difficult ventilation and contribute to patient safety. The use of common terminology can also facilitate the evaluation of the performance of intubation tools. The aim of this study was to evaluate the accuracy and intra and inter rater reliability of the POGO score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

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

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

December 27, 2019

Status Verified

May 1, 2019

Enrollment Period

26 days

First QC Date

May 21, 2019

Last Update Submit

December 26, 2019

Conditions

Intubation

Keywords

IntubationLaryngeal viewScoring systemsLarynx

Outcome Measures

Primary Outcomes (1)

  • Percentile of glottic opening

    A percentile of glottic opening score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening.

    2 minutes after induction of anesthesia

Interventions

VideolaryngoscopyDEVICE

Patient will be intubated by using videolaryngoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery and those who are intubated

You may qualify if:

  • Patients receiving general anesthesia

You may not qualify if:

  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Ünal

Ankara, 06300, Turkey (Türkiye)

Location

Related Publications (5)

  • Yentis SM, Lee DJ. Evaluation of an improved scoring system for the grading of direct laryngoscopy. Anaesthesia. 1998 Nov;53(11):1041-4. doi: 10.1046/j.1365-2044.1998.00605.x.

    PMID: 10023271BACKGROUND

  • Norris A, Heidegger T. Limitations of videolaryngoscopy. Br J Anaesth. 2016 Aug;117(2):148-50. doi: 10.1093/bja/aew122. Epub 2016 Jun 1. No abstract available.

    PMID: 27251753BACKGROUND

  • Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.

    PMID: 10522589BACKGROUND

  • Roznovan VK. [Condition of oxidation-reduction processes in patients with chronic osteomyelitis of the jaw and phlegmons of the maxillofacial area in connection with surgical intervention and anesthesia]. Stomatologiia (Mosk). 1975 Jan-Feb;54(1):33-6. No abstract available. Russian.

    PMID: 1054169BACKGROUND

  • Cook TM. A grading system for direct laryngoscopy. Anaesthesia. 1999 May;54(5):496-7. doi: 10.1046/j.1365-2044.1999.0907f.x. No abstract available.

    PMID: 10995154BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Dilek Ünal, Assoc. Prof.

    Netherlands: Ministry of Health, Welfare and Sports

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

May 30, 2019

Primary Completion

June 25, 2019

Study Completion

June 25, 2019

Last Updated

December 27, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)