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

Point of Care Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608202
• Other study ID #: AsociacionEPS
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: April 2022
• Source: Asociacion Española Primera en Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Point of Care Ultrasound

Intervention

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.

Other:
• Control group
Routine protocol of the treating team is followed

Locations

Country	Name	City	State
Uruguay	UCI Hospital Pasteur y Asociacion Española	Montevideo

Sponsors (2)

Lead Sponsor	Collaborator
Asociacion Española Primera en Salud	Intensive Care Unit Pasteur Hospital

Country where clinical trial is conducted

Uruguay, 

Outcome

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