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

Overview

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.

Full Title of Study: “Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2018

Interventions

  • Behavioral: POCUS 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.
  • Other: Control group
    • Routine protocol of the treating team is followed

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Definitive diagnosis
    • Time Frame: Up to 7 days
    • Delay in performing definitive diagnosis (hours)
  • ICU extra requirements
    • Time Frame: Up to 7 days
    • Requests for imaging studies (Number per patient)
  • Interventions
    • Time Frame: Up to 7 days
    • Number and type of procedures or interventions performed on the patient (Number per patient)
  • Delay times
    • Time Frame: Up to 7 days
    • Delay between the treatment decision and its actual completion (eg pleural drainage) (in hours)
  • Duration of mechanical ventilation
    • Time Frame: Up to 30 days
    • Time of invasive mechanical ventilation (days)
  • ICU stay
    • Time Frame: Up to 30 days
    • Internment time in ICU (days)
  • Mortality
    • Time Frame: Up to 30 days
    • Death rate (percentage)

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Asociacion Española Primera en Salud
    • Collaborator
      • Intensive Care Unit Pasteur Hospital
    • Provider of Information About this Clinical Study
      • Principal Investigator: Julio Pontet, MD, PhD – Asociacion Española Primera en Salud
    • Overall Contact(s)
      • Julio Pontet, MD, +59899649342, jpontet2003@gmail.com

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