The Evaluation of Simplified Predictive Intubation Difficulty Score.

NCT03320278 | Completed

• 1 other identifier: 2016/900/39
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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. The 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 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).

Conditions

Head and Neck Disorder; Difficult Intubation; Facial Deformity

Keywords

endotracheal intubation; airway management

Outcome Measures

Primary Outcomes (1)

• SPIDS

  SPIDS - Simplified Predictive Intubation Difficulty Score - calculated using patient history, mouth opening, maximum angle of head and neck mobility and modified Mallampati test

  6 months

Secondary Outcomes (1)

• comparing sensitivity and specificity of TMH and SPIDS in predicting difficult airway

  6 months

Study Arms (1)

SPIDS,TMH

There will be two tests in this study for evaluation. Both of them will be measured in same group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers in ENT and plastic surgery patients with possibly have maxillary,oral,head and neck pathologies

You may qualify if:

• Being volunteer
• Older than 18 years old
• Being undergoing planned elective surgery patients
• Being ENT or plastic surgery patient

You may not qualify if:

• Emergency operations
• Patients younger than 18 years old
• Being non-volunteer for the study
• Patients will not be orally intubated

Sponsors & Collaborators

• Maltepe University: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (1)

Maltepe University

Istanbul, Maltepe, Turkey (Türkiye)

Location

Related Publications (3)

• L'Hermite J, Nouvellon E, Cuvillon P, Fabbro-Peray P, Langeron O, Ripart J. The Simplified Predictive Intubation Difficulty Score: a new weighted score for difficult airway assessment. Eur J Anaesthesiol. 2009 Dec;26(12):1003-9. doi: 10.1097/EJA.0b013e32832efc71.

  PMID: 19593145 RESULT

• Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.

  PMID: 9602574 RESULT

• Etezadi F, Ahangari A, Shokri H, Najafi A, Khajavi MR, Daghigh M, Moharari RS. Thyromental height: a new clinical test for prediction of difficult laryngoscopy. Anesth Analg. 2013 Dec;117(6):1347-51. doi: 10.1213/ANE.0b013e3182a8c734.

  PMID: 24257384 RESULT

Related Links

• pubmed direct link

Study Officials

• Zeliha Ozer, Prof.

  Maltepe University Medica Faculty

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 25, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

TU (1)