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

Sponsor
Rijnstate Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03214809
Collaborator
(none)
100
1
2
15.7
6.4

Study Details

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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasound protocol
N/A

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.

Study Design

Study Type:
Interventional
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.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 :
Jan 18, 2019
Actual Primary Completion Date :
May 11, 2020
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients on the general wards in need of treatment by the MET team.
Exclusion Criteria:
  • age (<18 years),

  • pregnancy:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rijnstate Hospital Arnhem Netherlands

Sponsors and Collaborators

  • Rijnstate Hospital

Investigators

  • Principal Investigator: Michael Blans, MD, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT03214809
Other Study ID Numbers:
  • NL61884.091.17
First Posted:
Jul 12, 2017
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2020