Clinical trial NCT03608202: Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units
Official title: Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Point of Care Ultrasound
Keywords: Intensive Care
Point-of-Care Ultrasound
Thoracic Ultrasound
Diagnostic Techniques and procedures.
Lead sponsor: Asociacion Española Primera en Salud
Sponsor class: OTHER
Collaborators: name: Intensive Care Unit Pasteur Hospital
First posted: 2018-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in diagnosis and treatment by point of care ultrasound
timeFrame: Up to 7 days
Secondary outcomes:
measure: Definitive diagnosis
timeFrame: Up to 7 days
measure: ICU extra requirements
timeFrame: Up to 7 days
measure: Interventions
timeFrame: Up to 7 days
measure: Delay times
timeFrame: Up to 7 days
measure: Duration of mechanical ventilation
timeFrame: Up to 30 days
measure: ICU stay
timeFrame: Up to 30 days
measure: Mortality
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: UCI Hospital Pasteur y Asociacion Española
Study officials:
References:
citation: 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.