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CompletedNCT03608202Updated Apr 19, 2022

Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units

An interventional study of POCUS protocol group and Control group in Point of Care Ultrasound, sponsored by Asociacion Española Primera en Salud. Completed at 1 site in Uruguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by Asociacion Española Primera en Salud · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Ultrasound is a widely used tool for clinicians to manage severe acute patients, seeking to improve the limitations of traditional physical examination and special studies that require patient transfers and can be harmful. This study aims to determine that a pre-established protocol of multiorganic point-of-care ultrasound can be beneficial performed systematically in a critical care patient, improving the diagnosis, detecting hidden anomalies, generating changes in therapy and guiding interventions. A multicenter, randomized controlled clinical trial, against a conventional therapy group is designed. The study group underwent an ultrasound protocol at the entrance of an ICU, of optic, pulmonary, cardiac, abdominal and guide of interventions.

02

Conditions studied

  • Point of Care Ultrasound

Keywords

  • Intensive Care
  • Point-of-Care Ultrasound
  • Thoracic Ultrasound
  • Diagnostic Techniques and procedures.
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Admitted to the ICU with the requirement of Ventilatory Mechanical Assistance, and admitted for trauma, sepsis, shock of any cause, and postoperative major surgery.

Exclusion criteria

Exclusion Criteria:

  • More than 12 hours of previous hospitalization.
  • Those who refuse to enter the protocol.
  • Those considered by the treating team to be out of recovery possibilities or to enter to support Organ donation.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    POCUS protocol group

    POCUS protocol group It will be submitted to an ultrasound protocol which consists in performing the following ultrasound studies in each patient: Measurement of the diameter of the optic nerve. Neck. Pulmonary ultrasound (LUS score). Echocardiogram (function and volemia). Abdomen. Femoral vascular package. Eco-guided interventionism. Central venous accesses (controlling positioning with saline injection under ultrasound), arterial, pleural or abdominal drainage and percutaneous tracheotomy will be performed under ultrasound.

    Behavioral: POCUS protocol group

  • Active comparator
    Control group

    The usual handling will be followed. The studies will only be performed if the medical team-treating team considers it, requesting a radiologist specialist the same, as is done routinely.

    Other: Control group

Interventions

  • BehavioralPOCUS protocol group

    The findings of multiorgan ultrasound can modify diagnoses and treatments and immediate interventions (eg volume loading with saline solution, pleural or pericardial drainage, initiation of diuretics, increase in positive end expiratory pressure, etc.). This protocol is performed in the first 24 h of admission to the Intensive Care Unit (ICU) and is repeated at 24 h.

  • OtherControl group

    Routine protocol of the treating team is followed

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What researchers measure

Primary outcomes

  1. Changes in diagnosis and treatment by point of care ultrasound

    REGISTER OF (In terms of frequency): IN DIAGNOSIS: * Does not modify the initial diagnosis but confirms it * Induces a change in initial diagnosis * Discover an unknown initial diagnosis * Does not modify the initial diagnosis, does not discard or confirm anything and does not change the treatment that is done. * Induces a wrong diagnosis and leads to an error. IN TREATMENT: * Determines the performance of an urgent interventional diagnostic maneuver * Determines the performance of an urgent medical or pharmacological therapeutic maneuver of the ICU. * Determines the performance of an urgent interventional or surgical therapeutic maneuver

    Time frame: Up to 7 days

Secondary outcomes

  1. Definitive diagnosis

    Delay in performing definitive diagnosis (hours)

    Time frame: Up to 7 days

  2. ICU extra requirements

    Requests for imaging studies (Number per patient)

    Time frame: Up to 7 days

  3. Interventions

    Number and type of procedures or interventions performed on the patient (Number per patient)

    Time frame: Up to 7 days

  4. Delay times

    Delay between the treatment decision and its actual completion (eg pleural drainage) (in hours)

    Time frame: Up to 7 days

  5. Duration of mechanical ventilation

    Time of invasive mechanical ventilation (days)

    Time frame: Up to 30 days

  6. ICU stay

    Internment time in ICU (days)

    Time frame: Up to 30 days

  7. Mortality

    Death rate (percentage)

    Time frame: Up to 30 days

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Study locations

1 site
  • UCI Hospital Pasteur y Asociacion Española
    Montevideo, 14002, Uruguay
07

References and documents

Publications

  • Pontet J, Yic C, Diaz-Gomez JL, Rodriguez P, Sviridenko I, Mendez D, Noveri S, Soca A, Cancela M. Impact of an ultrasound-driven diagnostic protocol at early intensive-care stay: a randomized-controlled trial. Ultrasound J. 2019 Sep 30;11(1):24. doi: 10.1186/s13089-019-0139-2. PubMed 31595353 ↗

Individual participant data

Plan to share: Yes — Clinical and variable data of multiorganic focal ultrasonography

08

Registry details

Key details

Study ID
NCT03608202
Lead sponsor
Asociacion Española Primera en Salud
Collaborators
Intensive Care Unit Pasteur Hospital
Responsible party
Julio Pontet (MD, PhD, Asociacion Española Primera en Salud) — Principal investigator
First posted
Jul 31, 2018
Start date
Nov 2016
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update
Apr 19, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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