Clinical trial NCT03214809: The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
Official title: The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Coma
Hypotension and Shock
Keywords: ultrasound
MET team
Concordance
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age (\<18 years),
* pregnancy:

Primary outcomes:
measure: Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied
timeFrame: after 2-3 weeks
Secondary outcomes:
measure: Possible difference in diagnostic certainty
timeFrame: direct after inclusion
measure: Possible differences in initial treatment
timeFrame: direct after inclusion
measure: Possible differences in patients' disposition
timeFrame: direct after inclusion
measure: Whether the use of ultrasound was considered to be helpful
timeFrame: direct after inclusion
measure: MET physicians characteristics
timeFrame: direct after inclusion
measure: Possible difference in the time needed to reach a diagnosis
timeFrame: direct after inclusion
measure: Possible difference in the need for supervisor attendance
timeFrame: direct after inclusion
measure: Number of times ultrasound was used in te "non-ultrasound weeks"
timeFrame: direct after inclusion
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital
name: Michael Blans, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.