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

NCT03608202 | Completed DMC

• 1 other identifier: AsociacionEPS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Point of Care Ultrasound

Keywords

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

Outcome Measures

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

  Up to 7 days

Secondary Outcomes (7)

• Definitive diagnosis

  Up to 7 days

• ICU extra requirements

  Up to 7 days

• Interventions

  Up to 7 days

• Delay times

  Up to 7 days

• Duration of mechanical ventilation

  Up to 30 days

Study Arms (2)

POCUS protocol group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

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.

POCUS protocol group

Control group OTHER

Routine protocol of the treating team is followed

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociacion Española Primera en Salud: lead
• Intensive Care Unit Pasteur Hospital: collaborator

Study Sites (1)

UCI Hospital Pasteur y Asociacion Española

Montevideo, 14002, Uruguay

Location

Related Publications (1)

• 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.

  PMID: 31595353 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Controlled clinical trial. Prospective, randomized controlled clinical trial. The type of design is with posttest only and control group. Two groups will be compared, a study group ("experimental") undergoing a focal ultrasound protocol, versus a control group with conventional conventional management.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: July 31, 2018
• Study Start: November 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

UR (1)