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出境医 / 临床实验 / Evaluation of the Accuracy of the POGO Score

Evaluation of the Accuracy of the POGO Score

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
Layout table for study information
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
Arms and Interventions
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
Contacts and Locations
Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 23, 2019
Last Update Posted Date December 27, 2019
Actual Study Start Date May 30, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Accuracy of the POGO Score
Official Title Evaluation of the Accuracy and the Intra and Inter Rater Reliability of the POGO Score
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.

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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing surgery and those who are intubated
Condition Intubation
Intervention Device: Videolaryngoscopy
Patient will be intubated by using videolaryngoscope
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 3, 2019)
40
Original Estimated Enrollment
 (submitted: May 21, 2019)
20
Actual Study Completion Date June 25, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients receiving general anesthesia

Exclusion Criteria:

  • Emergency surgery
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03960567
Other Study ID Numbers POGO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
Study Sponsor Diskapi Teaching and Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Dilek Ünal, Assoc. Prof. Netherlands: Ministry of Health, Welfare and Sports
PRS Account Diskapi Teaching and Research Hospital
Verification Date May 2019