The Evaluation of Simplified Predictive Intubation Difficulty Score.

Evaluation of the Effectiveness of Simplified Predictive Intubation Difficulty Score in Difficult Airway

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).

Study Overview

• Status: Completed
• Conditions: Difficult Intubation; Head and Neck Disorder; Facial Deformity

Detailed Description

The investigators would like to evaluate consecutively patients, who applied to be operated in plastic surgery and ENT clinics due to head and neck pathologies which may cause difficult intubation, between May 2016 and December 2017 . The patients will be recruited to study consecutively therefore, there is going to be no randomization. The patients' height, age, weight, American Society of Anesthesiology (ASA) scores will be documented. Additionally, their Mallampati scores, thyromental distance, thyromental height, mouth opening values will be measured with ASIMETO DEPTH GAUGE digitally. Head and neck movement angle measurement will proceed in preoperative evaluation. In the operation room the intubation, determination of C-L and IDS are going to be operated by the anesthesiologist who is in charge of operating room and he or she will not be informed about airway assessments like SPIDS or TMH. The all difficult airway equipment will be readily prepared in advanced. Recorded data will be collected by the assistant researcher. The existing difficult intubation interventions will be determined by using IDS. The relationship between IDS, TMH and SPIDS values will be assessed in the means of predicting difficult airway.

Measurements:

Mallampati score: It has four grades and Mallampati 3 and 4 considered predictive factor for difficult intubation Thyromental distance (TMD): Short thyromental distance (TMD ≤ 6.5 cm) has been correlated with difficult direct laryngoscopic intubation in adult patients.

Thyromental height (TMH): This is a new technique for predicting difficult intubation and its accepted cut off is generally 5cm.

Height/Thyromental distance: Ratio of height in cm and thyromental distance in cm Intubation difficulty score (IDS): 0 is easy, 0-5 is slight difficulty and higher than 5 is moderate or serious difficulty in intubation.

The simplified descriptive intubation difficulty score (SPIDS): The maximum score can be 55 and the total score greater than 10,not SPIDS ≤ 10 is considered as difficult intubation. Calculation of SPIDS score following parameters is needed.

1. History of pathologies might be related to difficult intubation such as obstructive sleep apnea, facial malformations, cervical dislocation etc. no is 0, yes 10 is points
2. Mouth opening: ≥3.5 cm (0 points)- ≤3.5 cm (10 points)
3. Maximum head and neck measurement ≥80°(0 points), <80 (5 points)
4. Modified Mallampati test: class 1 (0 point ), class 2 (10 points), class 3 (15 points), class 4 (25 points)

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey
      • Maltepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SPIDS,TMH; There will be two tests in this study for evaluation. Both of them will be measured in same group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing sensitivity and specificity of TMH and SPIDS in predicting difficult airway	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.	6 months

Collaborators and Investigators

• Sponsor: Maltepe University
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Chair: Zeliha Ozer, Prof., Maltepe University Medica Faculty

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• pubmed direct link

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 3, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: endotracheal intubation; airway management
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2016/900/39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED