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

Not Applicable
Completed
Conditions
Point of Care Ultrasound
Interventions
Behavioral: POCUS protocol group
Other: Control group
Registration Number
NCT03608202
Lead Sponsor
Asociacion Española Primera en Salud
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
POCUS protocol groupPOCUS protocol groupPOCUS 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.
Control groupControl groupThe 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.
Primary Outcome Measures
NameTimeMethod
Changes in diagnosis and treatment by point of care ultrasoundUp 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 Outcome Measures
NameTimeMethod
Definitive diagnosisUp to 7 days

Delay in performing definitive diagnosis (hours)

ICU stayUp to 30 days

Internment time in ICU (days)

ICU extra requirementsUp to 7 days

Requests for imaging studies (Number per patient)

InterventionsUp to 7 days

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

Delay timesUp to 7 days

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

Duration of mechanical ventilationUp to 30 days

Time of invasive mechanical ventilation (days)

MortalityUp to 30 days

Death rate (percentage)

Trial Locations

Locations (1)

UCI Hospital Pasteur y Asociacion Española

🇺🇾

Montevideo, Uruguay

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