Clinical trial NCT06391840: Airway Ultrasound As an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery
Official title: Airway Ultrasound As an Independent Predictor of Difficult Laryngoscopy in Patients Receiving General Anesthesia for Elective Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Airway Ultrasound
Lead sponsor: G.Gennimatas General Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients above 28 years of age listed for elective surgery.

Brief summary: The goal of this observational study is to determine the usefulness of pre-operative airway ultrasound in predicting difficult laryngoscopy in patients receiving general anesthesia for elective surgery. The main question it aims to answer is the independent prognostic value of pre-operative airway ultrasound.


Eligibility criteria: Inclusion Criteria:

* listed for elective surgery
* airway assessment is possible prior to anesthesia

Exclusion Criteria:

* refusal to be enrolled in study
* airway assessment is not possible prior to anesthesia

Primary outcomes:
measure: Independent prognostic value of airway ultrasound in difficult laryngoscopy
timeFrame: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
Secondary outcomes:
measure: Search of normal and pathological values in airway ultrasound measurements
timeFrame: Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered
Other outcomes:
Locations:
city: Athens
country: Greece
facility: G. Gennimatas General Hospital
state: Attiki
Study officials:
affiliation: G.Gennimatas General Hospital
name: Dimitrios Katsaros
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carsetti A, Sorbello M, Adrario E, Donati A, Falcetta S. Airway Ultrasound as Predictor of Difficult Direct Laryngoscopy: A Systematic Review and Meta-analysis. Anesth Analg. 2022 Apr 1;134(4):740-750. doi: 10.1213/ANE.0000000000005839.
citation: You-Ten KE, Siddiqui N, Teoh WH, Kristensen MS. Point-of-care ultrasound (POCUS) of the upper airway. Can J Anaesth. 2018 Apr;65(4):473-484. doi: 10.1007/s12630-018-1064-8. Epub 2018 Jan 18.
citation: Adi O, Fong CP, Sum KM, Ahmad AH. Usage of airway ultrasound as an assessment and prediction tool of a difficult airway management. Am J Emerg Med. 2021 Apr;42:263.e1-263.e4. doi: 10.1016/j.ajem.2020.09.011. Epub 2020 Sep 14.
citation: Osman A, Sum KM. Role of upper airway ultrasound in airway management. J Intensive Care. 2016 Aug 15;4:52. doi: 10.1186/s40560-016-0174-z. eCollection 2016.
citation: Xu J, Wang B, Wang M, Yao W, Chen Y. The value of multiparameter combinations for predicting difficult airways by ultrasound. BMC Anesthesiol. 2022 Oct 5;22(1):311. doi: 10.1186/s12871-022-01840-0.
citation: Gottlieb M, Holladay D, Burns KM, Nakitende D, Bailitz J. Ultrasound for airway management: An evidence-based review for the emergency clinician. Am J Emerg Med. 2020 May;38(5):1007-1013. doi: 10.1016/j.ajem.2019.12.019. Epub 2019 Dec 11.