Point of Care UltrasoundNCT03608202
Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units
A study testing POCUS protocol group in people with Point of Care Ultrasound, run by Asociacion Española Primera en Salud at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Point of Care Ultrasound
- What is being tested?
- POCUS protocol group
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUruguay
- Study dates
- Nov 2016to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the ICU with the requirement of Ventilatory Mechanical Assistance, and admitted for trauma, sepsis, shock of any cause, and postoperative major surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study
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.
- Conditions
- Point of Care Ultrasound
- Being tested
- POCUS protocol group, Control group
- Keywords
- Intensive Care, Point-of-Care Ultrasound, Thoracic Ultrasound, Diagnostic Techniques and procedures.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUS protocol groupBehavioural
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.
Control groupOther
Routine protocol of the treating team is followed
| Study group | Role | What they receive |
|---|---|---|
| POCUS protocol group | Experimental | 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. Receives: Behavioral: POCUS protocol group |
| Control group | Active comparator | 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days
Secondary outcomes (7)
Definitive diagnosis
Delay in performing definitive diagnosis (hours)
Measured: Up to 7 days
ICU extra requirements
Requests for imaging studies (Number per patient)
Measured: Up to 7 days
Interventions
Number and type of procedures or interventions performed on the patient (Number per patient)
Measured: Up to 7 days
Delay times
Delay between the treatment decision and its actual completion (eg pleural drainage) (in hours)
Measured: Up to 7 days
Duration of mechanical ventilation
Time of invasive mechanical ventilation (days)
Measured: Up to 30 days
ICU stay
Internment time in ICU (days)
Measured: Up to 30 days
Mortality
Death rate (percentage)
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startNov 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Point of Care UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociacion Española Primera en Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care Unit Pasteur Hospital
- Responsible party
- Principal investigator, Julio Pontet, Asociacion Española Primera en Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608202
- Sponsor's protocol ID
- AsociacionEPS
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2017
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical and variable data of multiorganic focal ultrasonography
Publications
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.
PubMed 31595353
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multisystemic Ultrasound Protocol in Patients of Polyvalent Intensive Care Units. Multicenter Controlled Study
- ClinicalTrials.gov ID
- NCT03608202
- Acronym / sponsor ID
- AsociacionEPS
- Conditions
- Point of Care Ultrasound
- Keywords
- Intensive Care, Point-of-Care Ultrasound, Thoracic Ultrasound, Diagnostic Techniques and procedures.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asociacion Española Primera en SaludUniversity, hospital or other
- Collaborators
- Intensive Care Unit Pasteur Hospital
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| POCUS protocol group | Experimental | Behavioral: POCUS protocol groupPOCUS 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. |
| Control group | Active comparator | Other: Control groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted to the ICU with the requirement of Ventilatory Mechanical Assistance, and admitted for trauma, sepsis, shock of any cause, and postoperative major surgery.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUS protocol groupThe 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. | Behavioural | POCUS protocol group |
| Control groupRoutine protocol of the treating team is followed | Other | Control group |
Primary outcome
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
7 secondary outcomes
Definitive diagnosis
Time frame: Up to 7 days
ICU extra requirements
Time frame: Up to 7 days
Interventions
Time frame: Up to 7 days
Delay times
Time frame: Up to 7 days
Duration of mechanical ventilation
Time frame: Up to 30 days
ICU stay
Time frame: Up to 30 days
Mortality
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 31595353Pontet 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.
- Individual participant dataSharing planned: Yes. Clinical and variable data of multiorganic focal ultrasonography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POCUS protocol group in people with Point of Care Ultrasound, run by Asociacion Española Primera en Salud at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diagnosis and treatment by point of care ultrasound (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.