IntubationNCT03960567
Evaluation of the Accuracy of the POGO Score
An observational study of Intubation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation
- What is being tested?
- Videolaryngoscopy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2019to 25 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery and those who are intubated
Who may be able to join
- Patients receiving general anesthesia
Who cannot join
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy and the Intra and Inter Rater Reliability of the POGO Score
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.
Read the 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.
- Conditions
- Intubation
- Being tested
- Videolaryngoscopy
- Keywords
- Intubation, Laryngeal view, Scoring systems, Larynx
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopyDevice
Patient will be intubated by using videolaryngoscope
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start30 May 2019
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Dilek Ünal, Assoc. Prof., Principal investigator, Netherlands: Ministry of Health, Welfare and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960567
- Sponsor's protocol ID
- POGO
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10023271Norris 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.
PubMed 27251753Ochroch 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.
PubMed 10522589Roznovan 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.
PubMed 1054169Cook 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.
PubMed 10995154
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy and the Intra and Inter Rater Reliability of the POGO Score
- ClinicalTrials.gov ID
- NCT03960567
- Acronym / sponsor ID
- POGO
- Conditions
- Intubation
- Keywords
- Intubation, Laryngeal view, Scoring systems, Larynx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery and those who are intubated
Key inclusion criteria (1 listed)
- Patients receiving general anesthesia
Key exclusion criteria (1 listed)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideolaryngoscopyPatient will be intubated by using videolaryngoscope | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Background: PubMed 10023271Yentis 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.
- Background: PubMed 27251753Norris 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.
- Background: PubMed 10522589Ochroch 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.
- Background: PubMed 1054169Roznovan 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.
- Background: PubMed 10995154Cook 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Ünal, Assoc. Prof. principal investigator
Netherlands: Ministry of Health, Welfare and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentile of glottic opening (time frame: 2 minutes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960567, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.