Evaluation of the Accuracy of the POGO Score

• ClinicalTrials.gov Identifier: NCT03960567
• Recruitment Status: Completed
• First Posted: May 23, 2019
• Last Update Posted: December 27, 2019
• Sponsor: Diskapi Teaching and Research Hospital
• Information provided by (Responsible Party): DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Intubation	Device: Videolaryngoscopy

Detailed Description:

Anesthesiologist will be asked to score still images of laryngeal views, which will be obtained from patients requiring intubation for general anesthesia, after obtaining written informed consent.

The images of the larynx will be captured first with the Macintosh blade and thereafter with the D blade. A group of independent anesthesiologist will score these images with the Cormack Lehane and POGO scores. The set of images will be prepared from patients with both difficult and normal airway anatomy. Some images in the series will be repeated to assess intra rater variability.

The anesthesiologist will be asked to rate 20 images both with the CL and POGO scores.

The experience of the raters in airway management, their experience with videolaryngoscopy and scoring systems used currently when documenting videolaryngoscopy and demographic data will be also obtained.

The POGO scores of the participants and investigators will be compared.

The outcome of interest is the correct POGO score rate of the participants.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation of the Accuracy and the Intra and Inter Rater Reliability of the POGO Score
• Actual Study Start Date: May 30, 2019
• Actual Primary Completion Date: June 25, 2019
• Actual Study Completion Date: June 25, 2019

Groups and Cohorts

Intervention Details:

• Device: Videolaryngoscopy
  Patient will be intubated by using videolaryngoscope

Outcome Measures

Primary Outcome Measures :

1. Percentile of glottic opening [ Time Frame: 2 minutes after induction of anesthesia ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery and those who are intubated

Criteria

Inclusion Criteria:

• Patients receiving general anesthesia

Exclusion Criteria:

• Emergency surgery

Contacts and Locations

Locations

Turkey

Dilek Ünal

Ankara, Turkey, 06300

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

• Principal Investigator: Dilek Ünal, Assoc. Prof.; Netherlands: Ministry of Health, Welfare and Sports

More Information

Publications:

Yentis SM, Lee DJ. Evaluation of an improved scoring system for the grading of direct laryngoscopy. Anaesthesia. 1998 Nov;53(11):1041-4.

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.

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.

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. Russian.

Cook TM. A grading system for direct laryngoscopy. Anaesthesia. 1999 May;54(5):496-7.

• Responsible Party: DILEK YAZICIOGLU, Assoc Prof, Diskapi Teaching and Research Hospital
• ClinicalTrials.gov Identifier: NCT03960567
• Other Study ID Numbers: POGO
• First Posted: May 23, 2019
• Last Update Posted: December 27, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:

Intubation; Laryngeal view; Scoring systems; Larynx