NCT06391840

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 7, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

April 25, 2024

Last Update Submit

November 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Independent prognostic value of airway ultrasound in difficult laryngoscopy

    Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered

Secondary Outcomes (1)

  • Search of normal and pathological values in airway ultrasound measurements

    Airway assessment prior to anesthesia, usually 1-2 days before. Statistical analysis will be conducted after all data has been gathered

Study Arms (1)

Patients listed for elective surgery

Other: Airway ultrasound

Interventions

Pre-operative airway ultrasound

Patients listed for elective surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients above 28 years of age listed for elective surgery.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. Gennimatas General Hospital

Athens, Attica, 11527, Greece

RECRUITING

Related Publications (6)

  • 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.

    PMID: 34914641BACKGROUND
  • 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.

    PMID: 29349733BACKGROUND
  • 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.

    PMID: 32994082BACKGROUND
  • 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.

    PMID: 27529028BACKGROUND
  • 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.

    PMID: 36199026BACKGROUND
  • 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.

    PMID: 31843325BACKGROUND

Study Officials

  • Dimitrios Katsaros

    G.Gennimatas General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Katsaros

CONTACT

Tatiana Sidiropoulou

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dimitrios Katsaros, MD

Study Record Dates

First Submitted

April 25, 2024

First Posted

April 30, 2024

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

November 7, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations