NCT03608202|CompletedDMC
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Sponsor study identifier
interventional
80
1 country
1
Study Start
November 2016
Actual (reported)Primary Completion
May 31, 2017
Actual (reported)Study Completion
May 31, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2016
Actual (reported)March 14, 2017
Actual (reported)May 31, 2017
Actual (reported)May 31, 2017
Actual (reported)July 31, 2018
Actual (reported)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
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
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.
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.
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.
Routine protocol of the treating team is followed
UCI Hospital Pasteur y Asociacion Española
Montevideo, 14002, Uruguay
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.
80 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2017
First Posted
July 31, 2018
Study Start
Effects of Planned Training and Music Listened to Before a Cesarean Section on Surgical Fear, Anxiety and Depression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
November 2016
Actual (reported)Primary Completion
May 31, 2017
Actual (reported)Study Completion
May 31, 2017
Actual (reported)Last Updated
April 19, 2022
Record last verified: 2022-04
Clinical and variable data of multiorganic focal ultrasonography
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Source: ClinicalTrials.gov.
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