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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03608202
Enrollment
80
Registered
2018-07-31
Start date
2016-11-30
Completion date
2017-05-31
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Point of Care Ultrasound

Keywords

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

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.

Interventions

BEHAVIORALPOCUS 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.

OTHERControl group

Routine protocol of the treating team is followed

Sponsors

Intensive Care Unit Pasteur Hospital
CollaboratorUNKNOWN
Asociacion Española Primera en Salud
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in diagnosis and treatment by point of care ultrasoundUp to 7 daysREGISTER 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

MeasureTime frameDescription
ICU extra requirementsUp to 7 daysRequests for imaging studies (Number per patient)
InterventionsUp to 7 daysNumber and type of procedures or interventions performed on the patient (Number per patient)
Delay timesUp to 7 daysDelay between the treatment decision and its actual completion (eg pleural drainage) (in hours)
Definitive diagnosisUp to 7 daysDelay in performing definitive diagnosis (hours)
ICU stayUp to 30 daysInternment time in ICU (days)
MortalityUp to 30 daysDeath rate (percentage)
Duration of mechanical ventilationUp to 30 daysTime of invasive mechanical ventilation (days)

Countries

Uruguay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026