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

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

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.

Study Overview

• Status: Completed
• Conditions: Point of Care Ultrasound
• Intervention / Treatment: Behavioral: POCUS protocol group; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uruguay
  • Montevideo, Uruguay, 14002
    • UCI Hospital Pasteur y Asociacion Española

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; Routine protocol of the treating team is followed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asociacion Española Primera en Salud
• Collaborators: Intensive Care Unit Pasteur Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care; Point-of-Care Ultrasound; Thoracic Ultrasound; Diagnostic Techniques and procedures.
• Other Study ID Numbers: AsociacionEPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical and variable data of multiorganic focal ultrasonography

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No