Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Changes in diagnosis and treatment by point of care ultrasound
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Changes in diagnosis and treatment by point of care ultrasound
Time Frame: Up 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 Outcomes
- Definitive diagnosis(Up to 7 days)
- ICU stay(Up to 30 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)
- Mortality(Up to 30 days)
Investigators
Julio Pontet
MD, PhD
Asociacion Española Primera en Salud