search
Back to results

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

Primary Purpose

Dyspnea, Coma, Hypotension and Shock

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ultrasound protocol
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspnea focused on measuring ultrasound, MET team, Concordance

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • age (<18 years),
  • pregnancy:

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Thoracic ultrasound protocol

No Thoracic ultrasound protocol

Arm Description

ABCDE algorithm with Thoracic ultrasound protocol

ABCDE algorithm without Thoracic ultrasound protocol

Outcomes

Primary Outcome Measures

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

Possible difference in diagnostic certainty
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.
Possible differences in initial treatment
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.
Possible differences in patients' disposition
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.
Whether the use of ultrasound was considered to be helpful
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.
MET physicians characteristics
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.
Possible difference in the time needed to reach a diagnosis
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.
Possible difference in the need for supervisor attendance
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.
Number of times ultrasound was used in te "non-ultrasound weeks"
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

Full Information

First Posted
June 19, 2017
Last Updated
July 16, 2020
Sponsor
Rijnstate Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03214809
Brief Title
The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
Acronym
METUS
Official Title
The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow inclusion rate (partly due to Covid-19)
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
May 11, 2020 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Coma, Hypotension and Shock
Keywords
ultrasound, MET team, Concordance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic ultrasound protocol
Arm Type
Experimental
Arm Description
ABCDE algorithm with Thoracic ultrasound protocol
Arm Title
No Thoracic ultrasound protocol
Arm Type
No Intervention
Arm Description
ABCDE algorithm without Thoracic ultrasound protocol
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound protocol
Intervention Description
after first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor
Primary Outcome Measure Information:
Title
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied
Description
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.
Time Frame
after 2-3 weeks
Secondary Outcome Measure Information:
Title
Possible difference in diagnostic certainty
Description
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.
Time Frame
direct after inclusion
Title
Possible differences in initial treatment
Description
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.
Time Frame
direct after inclusion
Title
Possible differences in patients' disposition
Description
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.
Time Frame
direct after inclusion
Title
Whether the use of ultrasound was considered to be helpful
Description
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.
Time Frame
direct after inclusion
Title
MET physicians characteristics
Description
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.
Time Frame
direct after inclusion
Title
Possible difference in the time needed to reach a diagnosis
Description
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.
Time Frame
direct after inclusion
Title
Possible difference in the need for supervisor attendance
Description
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.
Time Frame
direct after inclusion
Title
Number of times ultrasound was used in te "non-ultrasound weeks"
Description
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
Time Frame
direct after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients on the general wards in need of treatment by the MET team. Exclusion Criteria: age (<18 years), pregnancy:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Blans, MD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34089087
Citation
Blans MJ, Bousie E, van der Hoeven JG, Bosch FH. A point-of-care thoracic ultrasound protocol for hospital medical emergency teams (METUS) improves diagnostic accuracy. Ultrasound J. 2021 Jun 4;13(1):29. doi: 10.1186/s13089-021-00229-3. Erratum In: Ultrasound J. 2021 Jun 16;13(1):31.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs