ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
ClinicalTrials.gov Identifier: NCT03320278
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
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. 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
Head and Neck Disorder Difficult Intubation 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 [Patient Registry]
Actual Enrollment : 153 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
Actual Study Completion Date : December 2017

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03320278


Locations
Turkey
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