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The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams (METUS)

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ClinicalTrials.gov Identifier: NCT03214809
Recruitment Status : Terminated (Slow inclusion rate (partly due to Covid-19))
First Posted : July 12, 2017
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rijnstate Hospital

Brief Summary:
Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET)

Condition or disease Intervention/treatment Phase
Dyspnea Coma Hypotension and Shock Diagnostic Test: ultrasound protocol Not Applicable

Detailed Description:

Rationale: Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams Objective: Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.

Study design prospective, interventional study Study population: patients on the general wards in need treatment by the MET team Intervention (if applicable): When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.

Main study parameters/endpoints:

Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied.

Also other secondary endpoints will be evaluated.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The use of ultrasound is without direct side effects in terms of radiation or other potential (non)physical disturbances.

There are no data on the effects of the use of ultrasound during MET calls. The MET team will first deliver acute care if necessary, the ultrasound protocol can be done within 10-15 minutes which is acceptable in terms of MET call care. The MET team physician can at any point decide to use the ultrasound if he/she thinks it is necessary.

In other circumstances (e.g. emergency department or intensive care units) point-of-care ultrasound is considered to be part of standard care.

The investigators will study the potential influence of ultrasound during MET calls in terms of accuracy of the initial diagnosis and whether ultrasound influences initial treatment, patients' disposition and so on, ultrasound is no treatment nor will be the use of ultrasound be decisive in the treatment of MET call patients in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
Actual Study Start Date : January 18, 2019
Actual Primary Completion Date : May 11, 2020
Actual Study Completion Date : May 11, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thoracic ultrasound protocol
ABCDE algorithm with Thoracic ultrasound protocol
Diagnostic Test: ultrasound protocol
after first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor

No Intervention: No Thoracic ultrasound protocol
ABCDE algorithm without Thoracic ultrasound protocol



Primary Outcome Measures :
  1. Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied [ Time Frame: after 2-3 weeks ]
    final diagnosis will be determined by 2 independent experts on the basis of chart review and will be compared with the MET team diagnosis. There are 8 pre defined diagnosis categories. The difference in concordance between the MET diagnosis with and without the use of ultrasound with the definitive diagnosis will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.


Secondary Outcome Measures :
  1. Possible difference in diagnostic certainty [ Time Frame: direct after inclusion ]
    diagnostic certainty is measured on a scale 0-10. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.

  2. Possible differences in initial treatment [ Time Frame: direct after inclusion ]
    There are 11 pre-defined therapy categories. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  3. Possible differences in patients' disposition [ Time Frame: direct after inclusion ]
    There are 4 pre-defined categories in patients' disposition. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  4. Whether the use of ultrasound was considered to be helpful [ Time Frame: direct after inclusion ]
    The answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  5. MET physicians characteristics [ Time Frame: direct after inclusion ]
    there are 5 pre-defined categories in MET physician characteristics. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  6. Possible difference in the time needed to reach a diagnosis [ Time Frame: direct after inclusion ]
    time in minutes. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.

  7. Possible difference in the need for supervisor attendance [ Time Frame: direct after inclusion ]
    the answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.

  8. Number of times ultrasound was used in te "non-ultrasound weeks" [ Time Frame: direct after inclusion ]
    answer to this question is a number. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients on the general wards in need of treatment by the MET team.

Exclusion Criteria:

  • age (<18 years),
  • pregnancy:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214809


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
Investigators
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Principal Investigator: Michael Blans, MD Rijnstate Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT03214809    
Other Study ID Numbers: NL61884.091.17
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rijnstate Hospital:
ultrasound
MET team
Concordance
Additional relevant MeSH terms:
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Dyspnea
Hypotension
Emergencies
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory