NCT05336448

Brief Summary

This is a prospective study that aims to assess the differences in point-of-care ultrasound assessment (POCUS) with portable and ultra-portable devices, using conventional vs artificial intelligence (AI) methodologies, performed by experienced vs inexperienced physicians, in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 27, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

March 26, 2022

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess artificial intelligence ultrasound software to assess various echocardiographic variables useful for the management of critically ill patients

    Assess the accuracy of automatic measurements to determine ultrasound parameters using portable versus ultra-portable ultrasound scanners. \- Assess the accuracy of POCUS performed by inexperienced professionals using portable versus ultraportable ultrasounds.

    up to 48 weeks

Eligibility Criteria

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

Patients admitted to the intensive care department which, according to the clinical assessment of the medical team, would benefit from an ultrasound assessment.

You may qualify if:

  • Patients aged 18 years or over, admitted to the intensive care department which, according to the clinical assessment of the medical team, would benefit from an ultrasound assessment.

You may not qualify if:

  • Patients with atrial fibrillation or other dysrhythmias;
  • Inappropriate acoustic window for ultrasound assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Garcia de Orta

Lisbon, Almada, 2801-267, Portugal

Location

Related Publications (1)

  • Varudo R, Gonzalez FA, Leote J, Martins C, Bacariza J, Fernandes A, Michard F. Machine learning for the real-time assessment of left ventricular ejection fraction in critically ill patients: a bedside evaluation by novices and experts in echocardiography. Crit Care. 2022 Dec 14;26(1):386. doi: 10.1186/s13054-022-04269-6.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant of Internal Medicine and Intensive Medicine, PhD student

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 20, 2022

Study Start

July 27, 2021

Primary Completion

May 29, 2022

Study Completion

June 11, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations