NCT04816435

Brief Summary

To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

March 23, 2021

Conditions

Airway Complication of AnesthesiaAnesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

  • Pretracheal fat thickness for intubation complexity

    The pretracheal fat at the level of the vocal cords will be evaluated with ultrasound, to discern if a certain thickness is related to a difficult laryngoscopic vision (understood as cormack 3 or 4)

    5 minutes

Interventions

Ultrasound testDIAGNOSTIC_TEST

Ultrasound evaluation of airway

Eligibility Criteria

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

Patients under general anesthesia with orotracheal intubation

You may qualify if:

  • Patients risk ASA I-IV
  • Non-urgent surgery under general anesthesia with orotracheal intubation
  • Acceptance to participate and grant written consent

You may not qualify if:

  • Urgent surgery
  • Patients with a history of craniocervical pathology (trauma, tumor, malformations)
  • Pregnancy
  • Patient Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Fundación Jimenez Díaz

Madrid, 28040, Spain

Location

Related Publications (1)

  • Madrid-Vazquez L, Casans-Frances R, Gomez-Rios MA, Cabrera-Sucre ML, Granacher PP, Munoz-Alameda LE. Machine learning models based on ultrasound and physical examination for airway assessment. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Oct;71(8):563-569. doi: 10.1016/j.redare.2024.05.006. Epub 2024 May 31.

    PMID: 38825182DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

ES(1)