Intubation;DifficultNCT03578601
Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery
An observational study of Intubation;Difficult, run by University of Padova at 1 site in Italy.
Trial summary
Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Thyroid surgery
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 17 Sep 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing thyroid surgery
Who may be able to join
- thyroid surgery
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study
Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation. We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.
Read the detailed description
Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation.
There are few scientific data about airway management and thyroid pathology and the incidence of difficult tracheal intubation in this specific kind of patient is largely variable from 0% to 12.9%. These data have been collected from little statistical samples (from 50 to 326 patients), the results aren't always unanimous and a study evaluating simultaneously all the risk factors for difficult intubation does not exist.
We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.
During pre-anesthetic assessment the following data will be collected:
Inter-incisor gap (cm) Mallampati test (1;2;3;4) Thyromental distance (cm) Prognathism (yes; no) Neck motility (<80°;80-90°;>90°) Total body weight (kg) History of difficult tracheal intubation (yes; no) Tracheal deviation at chest X-Ray (yes; no) Neck circumference (cm) Mediastinal goiter (yes; no) Histologic features (benign; carcinoma)
During the post-anesthesia it will be noted down the following:
Cormack scale (1; 2a; 2b; 3; 4) Number of necessary attempts to intubate (1;2;3;…) Time from induction to intubation (min) Necessity to use advanced airway management devices (Frova; Glidescope; Ambu-scope; fiber-optic; other)
- Conditions
- Intubation;Difficult
- Being tested
- Thyroid surgery
- Keywords
- Intubation, Difficult, thyroid
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid surgeryOther
Patient undergoing thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Thyroid surgery | Patient undergoing thyroid surgery Receives: Other: Thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult intubation incidence
Difficult intubation described as Cormack 3 or 4
Measured: through study completion, an average of 2 year
Secondary outcomes (11)
Histologic features (benign; carcinoma) as predictive parameter for difficult intubation
preoperative Histologic features (benign; carcinoma) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Neck circumference (cm) as predictive parameter for difficult intubation
preoperative Neck circumference (cm) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation
preoperative Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation
preoperative History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Total body weight (kg) as predictive parameter for difficult intubation
preoperative Total body weight (kg) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation
preoperative Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Thyromental distance (cm) as predictive parameter for difficult intubation
preoperative Thyromental distance (cm) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Mediastinal goiter (yes; no) as predictive parameter for difficult intubation
preoperative Mediastinal goiter (yes; no) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Prognathism (yes; no) as predictive parameter for difficult intubation
preoperative Prognathism (yes; no) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Mallampati test (1;2;3;4) as predictive parameter for difficult intubation
preoperative Mallampati test (1;2;3;4) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Inter-incisor gap (cm) as predictive parameter for difficult intubation
preoperative Inter-incisor gap (cm) as predictive parameter for difficult intubation
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Sep 2017
- Primary completion17 Sep 2018
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578601
- Sponsor's protocol ID
- 4133/AO/17
- Status last verified
- Sep 2018
- First submitted
- 19 Feb 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Probably all IPD will be shared at the end of the study
Publications
Petrini F, Accorsi A, Adrario E, Agro F, Amicucci G, Antonelli M, Azzeri F, Baroncini S, Bettelli G, Cafaggi C, Cattano D, Chinelli E, Corbanese U, Corso R, Della Puppa A, Di Filippo A, Facco E, Favaro R, Favero R, Frova G, Giunta F, Giurati G, Giusti F, Guarino A, Iannuzzi E, Ivani G, Mazzon D, Menarini M, Merli G, Mondello E, Muttini S, Nardi G, Pigna A, Pittoni G, Ripamonti D, Rosa G, Rosi R, Salvo I, Sarti A, Serafini G, Servadio G, Sgandurra A, Sorbello M, Tana F, Tufano R, Vesconi S, Villani A, Zauli M; Gruppo di Studio SIAARTI "Vie Aeree Difficili"; IRC e SARNePI; Task Force. Recommendations for airway control and difficult airway management. Minerva Anestesiol. 2005 Nov;71(11):617-57. No abstract available. English, Italian.
PubMed 16278626Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23.
PubMed 18946426Bouaggad A, Nejmi SE, Bouderka MA, Abbassi O. Prediction of difficult tracheal intubation in thyroid surgery. Anesth Analg. 2004 Aug;99(2):603-6, table of contents. doi: 10.1213/01.ANE.0000122634.69923.67.
PubMed 15271749Amathieu R, Smail N, Catineau J, Poloujadoff MP, Samii K, Adnet F. Difficult intubation in thyroid surgery: myth or reality? Anesth Analg. 2006 Oct;103(4):965-8. doi: 10.1213/01.ane.0000237305.02465.ee.
PubMed 17000813Meco BC, Alanoglu Z, Yilmaz AA, Basaran C, Alkis N, Demirer S, Cuhruk H. Does ultrasonographic volume of the thyroid gland correlate with difficult intubation? An observational study. Braz J Anesthesiol. 2015 May-Jun;65(3):230-4. doi: 10.1016/j.bjane.2014.06.004. Epub 2014 Oct 16.
PubMed 25925037Khan MN, Rabbani MZ, Qureshi R, Zubair M, Zafar MJ. The predictors of difficult tracheal intubations in patients undergoing thyroid surgery for euthyroid goitre. J Pak Med Assoc. 2010 Sep;60(9):736-8.
PubMed 21381580
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study
- ClinicalTrials.gov ID
- NCT03578601
- Acronym / sponsor ID
- 4133/AO/17
- Conditions
- Intubation;Difficult
- Keywords
- Intubation, Difficult, thyroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 6 Jul 2018 (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.
Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation. We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.
Detailed description
Intubation manoeuvres in patients undergoing thyroid surgery might be challenging for anesthesiologist. Thyroid gland enlargement (goiter) or tissue fibrosis (neoplasms) could alter the physiologic anatomy of upper airways and trachea, resulting in compression or dislocation.
There are few scientific data about airway management and thyroid pathology and the incidence of difficult tracheal intubation in this specific kind of patient is largely variable from 0% to 12.9%. These data have been collected from little statistical samples (from 50 to 326 patients), the results aren't always unanimous and a study evaluating simultaneously all the risk factors for difficult intubation does not exist.
We want to evaluate the incidence and identify predictive parameters of difficult intubation in patients undergoing thyroid surgery.
During pre-anesthetic assessment the following data will be collected:
Inter-incisor gap (cm) Mallampati test (1;2;3;4) Thyromental distance (cm) Prognathism (yes; no) Neck motility (<80°;80-90°;>90°) Total body weight (kg) History of difficult tracheal intubation (yes; no) Tracheal deviation at chest X-Ray (yes; no) Neck circumference (cm) Mediastinal goiter (yes; no) Histologic features (benign; carcinoma)
During the post-anesthesia it will be noted down the following:
Cormack scale (1; 2a; 2b; 3; 4) Number of necessary attempts to intubate (1;2;3;…) Time from induction to intubation (min) Necessity to use advanced airway management devices (Frova; Glidescope; Ambu-scope; fiber-optic; other)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid surgery | – | Other: Thyroid surgeryPatient undergoing thyroid surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing thyroid surgery
Key inclusion criteria (1 listed)
- thyroid surgery
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid surgeryPatient undergoing thyroid surgery | Other | Thyroid surgery |
Primary outcome
Difficult intubation incidence
Time frame: through study completion, an average of 2 year
Difficult intubation described as Cormack 3 or 4
11 secondary outcomes
Histologic features (benign; carcinoma) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Neck circumference (cm) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Tracheal deviation at chest X-Ray (yes; no) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
History of difficult tracheal intubation (yes; no) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Total body weight (kg) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Neck motility (<80°;80-90°;>90°) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Thyromental distance (cm) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Mediastinal goiter (yes; no) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Prognathism (yes; no) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Mallampati test (1;2;3;4) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
Inter-incisor gap (cm) as predictive parameter for difficult intubation
Time frame: through study completion, an average of 2 year
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 20 Sep 2018.
- Background: PubMed 16278626Petrini F, Accorsi A, Adrario E, Agro F, Amicucci G, Antonelli M, Azzeri F, Baroncini S, Bettelli G, Cafaggi C, Cattano D, Chinelli E, Corbanese U, Corso R, Della Puppa A, Di Filippo A, Facco E, Favaro R, Favero R, Frova G, Giunta F, Giurati G, Giusti F, Guarino A, Iannuzzi E, Ivani G, Mazzon D, Menarini M, Merli G, Mondello E, Muttini S, Nardi G, Pigna A, Pittoni G, Ripamonti D, Rosa G, Rosi R, Salvo I, Sarti A, Serafini G, Servadio G, Sgandurra A, Sorbello M, Tana F, Tufano R, Vesconi S, Villani A, Zauli M; Gruppo di Studio SIAARTI "Vie Aeree Difficili"; IRC e SARNePI; Task Force. Recommendations for airway control and difficult airway management. Minerva Anestesiol. 2005 Nov;71(11):617-57. No abstract available. English, Italian.
- Background: PubMed 18946426Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23.
- Results publication: PubMed 15271749Bouaggad A, Nejmi SE, Bouderka MA, Abbassi O. Prediction of difficult tracheal intubation in thyroid surgery. Anesth Analg. 2004 Aug;99(2):603-6, table of contents. doi: 10.1213/01.ANE.0000122634.69923.67.
- Results publication: PubMed 17000813Amathieu R, Smail N, Catineau J, Poloujadoff MP, Samii K, Adnet F. Difficult intubation in thyroid surgery: myth or reality? Anesth Analg. 2006 Oct;103(4):965-8. doi: 10.1213/01.ane.0000237305.02465.ee.
- Results publication: PubMed 25925037Meco BC, Alanoglu Z, Yilmaz AA, Basaran C, Alkis N, Demirer S, Cuhruk H. Does ultrasonographic volume of the thyroid gland correlate with difficult intubation? An observational study. Braz J Anesthesiol. 2015 May-Jun;65(3):230-4. doi: 10.1016/j.bjane.2014.06.004. Epub 2014 Oct 16.
- Results publication: PubMed 21381580Khan MN, Rabbani MZ, Qureshi R, Zubair M, Zafar MJ. The predictors of difficult tracheal intubations in patients undergoing thyroid surgery for euthyroid goitre. J Pak Med Assoc. 2010 Sep;60(9):736-8.
- Individual participant dataSharing planned: Undecided. Probably all IPD will be shared at the end of the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intubation;Difficult, run by University of Padova at 1 site in Italy.
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 1 inclusion and 1 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 20 Sep 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 Italy. 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?
Difficult intubation incidence (time frame: through study completion, an average of 2 year). 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 NCT03578601, which also lists 6 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 20 Sep 2018.