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Critical IllnessPocusAI-CritNCT05336448

POCUS AI in Critically Ill Patients

An observational study of Critical Illness, run by Hospital Garcia de Orta at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
How many people
99 participants
Where
1 sitePortugal
Study dates
27 Jul 2021to 11 Jun 2022
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Hospital Garcia de Orta

    Lisbon, Almada, 2801-267

Other trials in Portugal

About this study

Official title: POCUS Artificial Intelligence With Portable and Ultraportable Ultrasound Devices in Critically Ill Patients

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.

Read the detailed description
  1. Type of Study Prospective study.
  2. Sample Individuals, aged 18 years or over, admitted to the intensive care department, according to the clinical assessment of the medical team, benefit from an ultrasound assessment.

Convenient sample size up to 100 patients

Exclusion criteria:

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

  1. Devices used The study in question aims to perform an ultrasound using two ultrasound scanners belonging to the Intensive Care Department:
  • VenueTM The VenueTM is a portable ultrasound device from GE Healthcare, with touch screen technology, which allows the performance of transthoracic echocardiography and chest ultrasound with M-mode, two-dimensional (2D) and Doppler (color, pulsed, continuous and tissue). Additionally, it uses methodologies that allow the automatic measurement of parameters such as left ventricular ejection fraction, inferior vena cava diameter and its variability, integral time-velocity of flow in the left ventricular outflow tract.
  • Butterfly iQ+ The Butterly iQ+ is an ultra-portable ultrasound device, belonging to devices commonly called pocket devices, measuring 163 x 56 x 35 mm. It has a rechargeable battery that allows an autonomy of 2 hours of continuous use. By connecting to a smartphone and after installing the brand application, it allows the performance of transthoracic and pulmonary echocardiography with M-mode, two-dimensional (2D) and color Doppler. It also allows automatic determination of left ventricular ejection fraction. Acquiring images for later review is also possible with this device. d. Variables Demographic, clinical, hemodynamic and respiratory monitoring, laboratory variables - including troponin T, NT-proBNP, creatinine, urea, sodium, potassium, lactate, when available -, severity and mortality scores (SOFA, SAPS- II, APACHE-II) and ultrasound variables. - Echographic variables - transthoracic echocardiography: Acoustic window: nominal qualitative variable, expressed as "good", "reasonable" or "technically difficult". Patient positioning: nominal qualitative variable, expressed in "left lateral decubitus", "right lateral decubitus" or "supine position".

In the 4-chamber apical window (A4C), the following variables should be evaluated (by a physician experienced in echocardiography), with the

Butterfly iQ+ device and then with the VenueTM:

  • Left Ventricular Ejection Fraction (LVEF) manual: discrete quantitative variable, expressed in %; refers to the manual measurement of LVEF, obtained through the LV volumes in end-diastole and in end-systole. In the A4C window, the following variables should be evaluated (by a physician experienced in echocardiography and an inexperienced physician), with the Butterfly iQ+ device and then with the VenueTM:
  • LVEF auto: discrete quantitative variable, expressed in %; refers to the determination of LVEF through automatic methodology. In the 5-chamber apical window (A5C), the following variables should be evaluated (with the VenueTM device and by a physician experienced in echocardiography):
  • Left ventricular outflow tract velocity time integral (LVOT VTI) manual: discrete quantitative variable, expressed in cm; refers to manual measurement of the LVOT VTI. In the A5C window, the following variables should be evaluated (by a physician experienced in echocardiography and an inexperienced physician), with the VenueTM device:
  • LVOT VTI auto: discrete quantitative variable, expressed in cm; refers to the determination of the LVOT VTI through automatic methodology, whose calculation will result from the average of 3 consecutive cycles. In the subcostal window, the following variables should be evaluated (by a physician experienced in echocardiography), with the Butterfly iQ+ device and then with the VenueTM: • Maximum diameter of the manual inferior vena cava (IVC): continuous quantitative variable, expressed in mm, to one decimal place; refers to manual measurement of VCI. • Minimum diameter of manual IVC: continuous quantitative variable, expressed in mm, to one decimal place; refers to manual measurement of VCI. Manual IVC diameter variation: discrete quantitative variable, expressed in %. In the subcostal window, they must be evaluated (by a physician experienced in echocardiography and inexperienced physician), with the

VenueTM device, the following variables:

  • Maximum diameter of the inferior vena cava (IVC) auto: continuous quantitative variable, expressed in mm, to one decimal place; refers to the determination of the diameter of the VCI through automatic methodology.
  • Minimum diameter of auto VCI: continuous quantitative variable, expressed in mm, to one decimal place; refers to the determination of the diameter of the VCI through automatic methodology.
  • Auto IVC diameter variation: discrete quantitative variable, expressed in %. e. Methodology - study stages The ultrasound evaluation of each patient included in the study will be performed by two different doctors. It is intended to evaluate the variables previously discriminated by an experienced doctor in ultrasound and by a non-experienced doctor. Each parameter must be checked in triplicate and registered.

Regarding the echocardiographic assessment, experienced physicians should determine the echographic variables in a conventional way (manual) and also through an automatic methodology, first using the Butterfly iQ+ device and later the VenueTM device. Non-experienced physicians will only perform the determination of variables using the automatic methodology (therefore only the variables for which this option is available). The collection of parameters related to the echocardiographic evaluation will be performed in a previously established order in order to avoid bias in subsequent comparisons. Blood pressure, heart rate, respiratory rate and peripheral oxygen saturation should be recorded during the ultrasound assessment. Regarding laboratory variables, the results available in the analysis of the patient on the day of the ultrasound evaluation will be considered (an additional study will not be requested if any of the measurements has not been previously requested by the attending physician). Any need for vasopressor, inotropic or invasive mechanical ventilation should also be recorded. e) Collection and recording of data Demographic and clinical variables will be collected using the patients' clinical records. The variables referring to the ultrasound assessment will be recorded at the time of their acquisition in the CRF.

Medical subject headings
Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start27 Jul 2021
  3. Primary completion29 May 2022
  4. Study completion11 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
99 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336448
Sponsor's protocol ID
TI 71/2021
Acronym
PocusAI-Crit
Status last verified
Sep 2022
First submitted
26 Mar 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36517906

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness, run by Hospital Garcia de Orta at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess artificial intelligence ultrasound software to assess various echocardiographic variables useful for the management of critically ill patients (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05336448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

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