Trial record 2 of 4 for:    9602574 [PUBMED-IDS]

The Evaluation of Simplified Predictive Intubation Difficulty Score.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03320278
Recruitment Status : Active, not recruiting
First Posted : October 25, 2017
Last Update Posted : February 20, 2018
Sisli Hamidiye Etfal Training and Research Hospital
Information provided by (Responsible Party):
Onur Selvi, Maltepe University

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. 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
Observational Model: Cohort
Time Perspective: Prospective
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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
155 volunteers in ENT and plastic surgery patients with possibly have maxillary,oral,head and neck pathologies

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03320278

Maltepe University
Istanbul, Maltepe, Turkey
Sponsors and Collaborators
Maltepe University
Sisli Hamidiye Etfal Training and Research Hospital
Study Chair: Zeliha Ozer, Prof. Maltepe University Medica Faculty