Intubation;Difficult Clinical Trial
Official title:
Predictive Parameters for Difficult Tracheal Intubation Identification in Thyroid Surgery, a Observational Monocentric Prospective Study
Verified date | September 2018 |
Source | University of Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 17, 2018 |
Est. primary completion date | September 17, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - thyroid surgery Exclusion Criteria: - <18 years |
Country | Name | City | State |
---|---|---|---|
Italy | University of Padova | Padova |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
Amathieu 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. — View Citation
Bouaggad 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. — View Citation
Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Epub 2008 Oct 23. Review. — View Citation
Khan 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. — View Citation
Meco 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 — View Citation
Petrini F, Accorsi A, Adrario E, Agrò 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. English, Italian. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difficult intubation incidence | Difficult intubation described as Cormack 3 or 4 | through study completion, an average of 2 year | |
Secondary | Histologic features (benign; carcinoma) as predictive parameter for difficult intubation | preoperative Histologic features (benign; carcinoma) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | Neck circumference (cm) as predictive parameter for difficult intubation | preoperative Neck circumference (cm) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | 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 | through study completion, an average of 2 year | |
Secondary | 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 | through study completion, an average of 2 year | |
Secondary | Total body weight (kg) as predictive parameter for difficult intubation | preoperative Total body weight (kg) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | 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 | through study completion, an average of 2 year | |
Secondary | Thyromental distance (cm) as predictive parameter for difficult intubation | preoperative Thyromental distance (cm) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | Mediastinal goiter (yes; no) as predictive parameter for difficult intubation | preoperative Mediastinal goiter (yes; no) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | Prognathism (yes; no) as predictive parameter for difficult intubation | preoperative Prognathism (yes; no) as predictive parameter for difficult intubation | through study completion, an average of 2 year | |
Secondary | 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 | through study completion, an average of 2 year | |
Secondary | Inter-incisor gap (cm) as predictive parameter for difficult intubation | preoperative Inter-incisor gap (cm) as predictive parameter for difficult intubation | through study completion, an average of 2 year |
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