Difficult Intubation Clinical Trial
Official title:
Evaluation of the Effectiveness of Simplified Predictive Intubation Difficulty Score in Difficult Airway
NCT number | NCT03320278 |
Other study ID # | 2016/900/39 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | December 2017 |
Verified date | November 2018 |
Source | Maltepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
Status | Completed |
Enrollment | 153 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Maltepe University | Istanbul | Maltepe |
Lead Sponsor | Collaborator |
---|---|
Maltepe University | Sisli Hamidiye Etfal Training and Research Hospital |
Turkey,
Arné J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Ariès 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. — View Citation
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. — View Citation
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.0b013e328 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03657927 -
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
|
N/A | |
Enrolling by invitation |
NCT04506346 -
Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
|
||
Completed |
NCT02944305 -
A Predictive Model for Difficult Intubation
|
N/A | |
Completed |
NCT02476565 -
Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
|
N/A | |
Completed |
NCT02823392 -
Difficult Bag Mask Ventilation and Difficult Intubation in Children
|
||
Completed |
NCT05347680 -
A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain
|
N/A | |
Completed |
NCT03265938 -
Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology
|
||
Completed |
NCT05545982 -
Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation
|
N/A | |
Completed |
NCT01532063 -
Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea
|
N/A | |
Completed |
NCT03709524 -
Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation
|
N/A | |
Recruiting |
NCT03902704 -
Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation
|
N/A | |
Not yet recruiting |
NCT05607433 -
Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation
|
N/A | |
Completed |
NCT02814266 -
Difficult Intubation and Anthropometric Measurement
|
N/A | |
Active, not recruiting |
NCT04759287 -
Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation
|
N/A | |
Completed |
NCT03547193 -
Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy
|
||
Completed |
NCT04822831 -
The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients
|
N/A | |
Completed |
NCT03165461 -
Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
|
||
Recruiting |
NCT02177240 -
A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.
|
N/A | |
Recruiting |
NCT01612949 -
Facial Analysis to Classify Difficult Intubation
|
||
Completed |
NCT04168840 -
Ultrasound Parameters to Predict Difficult Airway
|