Head and Neck DisorderNCT03320278
The Evaluation of Simplified Predictive Intubation Difficulty Score.
An observational study of Head and Neck Disorder and Difficult Intubation, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Disorder, Difficult Intubation, Facial Deformity
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2016to Dec 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers in ENT and plastic surgery patients with possibly have maxillary,oral,head and neck pathologies
Who may be able to join
- Being volunteer
- Older than 18 years old
- Being undergoing planned elective surgery patients
- Being ENT or plastic surgery patient
Who cannot join
- Emergency operations
- Patients younger than 18 years old
- Being non-volunteer for the study
- Patients will not be orally intubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- 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
- Mouth opening: ≥3.5 cm (0 points)- ≤3.5 cm (10 points)
- Maximum head and neck measurement ≥80°(0 points), <80 (5 points)
- Modified Mallampati test: class 1 (0 point ), class 2 (10 points), class 3 (15 points), class 4 (25 points)
- Keywords
- endotracheal intubation, airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SPIDS,TMH | There will be two tests in this study for evaluation. Both of them will be measured in same group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPIDS
SPIDS - Simplified Predictive Intubation Difficulty Score - calculated using patient history, mouth opening, maximum angle of head and neck mobility and modified Mallampati test
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study startOct 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Responsible party
- Principal investigator, Onur Selvi, Maltepe University
- Investigators
- Zeliha Ozer, Prof., Study chair, Maltepe University Medica Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320278
- Sponsor's protocol ID
- 2016/900/39
- Status last verified
- Nov 2018
- First submitted
- 24 Oct 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 19593145Arne 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.
PubMed 9602574Etezadi 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.
PubMed 24257384
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Simplified Predictive Intubation Difficulty Score in Difficult Airway
- ClinicalTrials.gov ID
- NCT03320278
- Acronym / sponsor ID
- 2016/900/39
- Keywords
- endotracheal intubation, airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Collaborators
- Sisli Hamidiye Etfal Training and Research Hospital
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- 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
- Mouth opening: ≥3.5 cm (0 points)- ≤3.5 cm (10 points)
- Maximum head and neck measurement ≥80°(0 points), <80 (5 points)
- Modified Mallampati test: class 1 (0 point ), class 2 (10 points), class 3 (15 points), class 4 (25 points)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPIDS,TMH | – | –There will be two tests in this study for evaluation. Both of them will be measured in same group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers in ENT and plastic surgery patients with possibly have maxillary,oral,head and neck pathologies
Key inclusion criteria (4 listed)
- Being volunteer
- Older than 18 years old
- Being undergoing planned elective surgery patients
- Being ENT or plastic surgery patient
Key exclusion criteria (4 listed)
- Emergency operations
- Patients younger than 18 years old
- Being non-volunteer for the study
- Patients will not be orally intubated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
comparing sensitivity and specificity of TMH and SPIDS in predicting difficult airway
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Results publication: PubMed 19593145L'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.
- Results publication: PubMed 9602574Arne 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.
- Results publication: PubMed 24257384Etezadi 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.
- pubmed direct linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Ozer, Prof. study chair
Maltepe University Medica Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Disorder and Difficult Intubation, run by Maltepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPIDS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320278, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.