The Evaluation of Simplified Predictive Intubation Difficulty Score.
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|ClinicalTrials.gov Identifier: NCT03320278|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : February 20, 2018
Difficult intubation is considered one of the most important obstacle increasing mortality in anesthesiology. Airway assessment tests are proceeded to overcome these difficulties in the pre-anesthetic evaluation. In this study, the Simplified Predictive Intubation Difficulty Score (SPIDS) and Thyromental Height Measurement (TMH) were chosen as primary methods to predict difficult intubation. Total 155 ear-nose-throat (ENT) and Plastic Surgery patients were planned to enroll this study to assess the effectiveness of these tests in predicting difficult intubation in 155 in Maltepe University Hospital and Sisli Hamidiye Etfal Governmental Hospital.
The SPIDS of volunteers will be calculated according to their previous knowledge of difficult intubation, airway pathologies, head and neck movements, mouth opening, modified Mallampati test and thyromental distance. TMH value will be measured with ASIMETO depth device. Finally, the SPIDS and TMH values will be statistically compared to predict difficult intubation which is determined with difficult intubation score (IDS).
|Condition or disease|
|Head and Neck Disorder Difficult Intubation Facial Deformity|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||155 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Evaluation of the Effectiveness of Simplified Predictive Intubation Difficulty Score in Difficult Airway|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
There will be two tests in this study for evaluation. Both of them will be measured in same group. (155 patients)
- SPIDS [ Time Frame: 6 months ]SPIDS - Simplified Predictive Intubation Difficulty Score - calculated using patient history, mouth opening, maximum angle of head and neck mobility and modified Mallampati test
- comparing sensitivity and specificity of TMH and SPIDS in predicting difficult airway [ Time Frame: 6 months ]TMH with cut off value is 5cm is considered as a good predictor for difficult airway. SPIDS is greater than 10 is considered as difficult intubation. Comparing this two measurement techniques for predicting difficult intubations will be calculated with Receiver Operating characteristics (ROC) analyses.
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): NCT03320278
|Istanbul, Maltepe, Turkey|
|Study Chair:||Zeliha Ozer, Prof.||Maltepe University Medica Faculty|