The Evaluation of Simplified Predictive Intubation Difficulty Score.

Sponsor
Maltepe University (Other)
Overall Status
Completed
CT.gov ID
NCT03320278
Collaborator
Sisli Hamidiye Etfal Training and Research Hospital (Other)
153
1
14
10.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    153 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Effectiveness of Simplified Predictive Intubation Difficulty Score in Difficult Airway
    Actual Study Start Date :
    Oct 1, 2016
    Actual Primary Completion Date :
    Dec 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    SPIDS,TMH

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

    Outcome Measures

    Primary Outcome Measures

    1. SPIDS [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maltepe University Istanbul Maltepe Turkey

    Sponsors and Collaborators

    • Maltepe University
    • Sisli Hamidiye Etfal Training and Research Hospital

    Investigators

    • Study Chair: Zeliha Ozer, Prof., Maltepe University Medica Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Onur Selvi, assistant professor, Maltepe University
    ClinicalTrials.gov Identifier:
    NCT03320278
    Other Study ID Numbers:
    • 2016/900/39
    First Posted:
    Oct 25, 2017
    Last Update Posted:
    Nov 6, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Onur Selvi, assistant professor, Maltepe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 6, 2018