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Completed

NCT Number: NCT03608202

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

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.

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Key information

Conditions

Point of Care Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Hospital Pasteur y Asociacion Española

Montevideo, 14002, Uruguay

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

POCUS protocol group

Behavioral

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.

Control Group

Other

Routine protocol of the treating team is followed

Primary outcomes

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

    Time frame: Up to 7 days

    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

Secondary outcomes

  1. Definitive diagnosis

    Time frame: Up to 7 days

    Delay in performing definitive diagnosis (hours)

  2. ICU extra requirements

    Time frame: Up to 7 days

    Requests for imaging studies (Number per patient)

  3. Interventions

    Time frame: Up to 7 days

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

  4. Delay times

    Time frame: Up to 7 days

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

  5. Duration of mechanical ventilation

    Time frame: Up to 30 days

    Time of invasive mechanical ventilation (days)

  6. ICU stay

    Time frame: Up to 30 days

    Internment time in ICU (days)

  7. Mortality

    Time frame: Up to 30 days

    Death rate (percentage)

Sponsors and collaborators

Lead sponsor

Asociacion Española Primera en Salud

Other

Collaborators

  • Intensive Care Unit Pasteur Hospital

Registry information

Official study title

Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2018
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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