Randomized study of Early Assessment by CT scanning in Trauma patients.

A randomized comparison of the bi-located Traumacenter North-West Netherlands, evaluating the presence of a Shockroom CT scanner on patient outcome and operations research.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22108

Enrollment

1124

Registered

2005-08-05

Start date

2005-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute traumatische letsels, veroorzaakt door externe oorzaken

Interventions

Patients are transported to either the VUmc or the AMC, based on randomization. Trauma care will remain the same for both institutions, with the only difference the location of the CT scanner.

Eligibility

Inclusion criteria

Inclusion criteria: All patients that are transported to the AMC or VUmc shockroom according to current pre-hospital triage system based on: 1. Injury mechanism; 2. Revised Trauma Score; 3. Presence or absence of traumatic brain injury.

Exclusion criteria

Exclusion criteria: Excluded from analysis and comparison are: 1. Patients younger than 16 years of age; 2. Death during transport to the hospital.

Design outcomes

Primary

Measure	Time frame
The number of days spent outside the hospital in the first year following the emergency admission in the shockroom will be our primary outcome. This outcome is responsive to differences in mortality (no more/additional days outside hospital), to differences in hospital stay for the initial admission, to differences in readmission rate (i.e. because of missed diagnoses). Furthermore, there is a positive association between a shorter hospital stay and better functional health. Care will be given to harmonize discharge criteria between the two hospitals.	—

Measure

Time frame

The number of days spent outside the hospital in the first year following the emergency admission in the shockroom will be our primary outcome. This outcome is responsive to differences in mortality (no more/additional days outside hospital), to differences in hospital stay for the initial admission, to differences in readmission rate (i.e. because of missed diagnoses). Furthermore, there is a positive association between a shorter hospital stay and better functional health. Care will be given to harmonize discharge criteria between the two hospitals.

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Secondary

Measure	Time frame
The secondary outcome parameters for the patient outcome part of the study will focus on: 1. The process of care parameters of the initial admission. This will include the comparison of various time intervals relevant in trauma care: 1.1 time to obtain results of CT imaging; 1.2 time to operation or other interventions (door-to-treatment time); 1.3 time to active bleed managing; 1.4 time to definitive care facility (ICU, high care, nursing ward); 1.5 duration of intensive care treatment; 1.6 time to discharge from the hospital; 2. Radiological examinations and findings: 2.1 The frequency and type of radiological examinations in each strategy; 2.2 description of the number, type and severity of diagnoses categorized by imaging modality in each strategy; 3. General health. This will be measured in all patients at 6 and 12 months after the shockroom admission using the EuroQol and HUI3 questionnaires; 4. All-cause mortality. This will include both in-hospital mortality and mortality during the first year following the trauma; 5. Radiation dose. The mean radiation dose will be calculated in both strategies based on the actual number and type of radiological examinations related to the initial trauma performed in each patient during the first year.	—

Measure

Time frame

The secondary outcome parameters for the patient outcome part of the study will focus on: 1. The process of care parameters of the initial admission. This will include the comparison of various time intervals relevant in trauma care: 1.1 time to obtain results of CT imaging; 1.2 time to operation or other interventions (door-to-treatment time); 1.3 time to active bleed managing; 1.4 time to definitive care facility (ICU, high care, nursing ward); 1.5 duration of intensive care treatment; 1.6 time to discharge from the hospital; 2. Radiological examinations and findings: 2.1 The frequency and type of radiological examinations in each strategy; 2.2 description of the number, type and severity of diagnoses categorized by imaging modality in each strategy; 3. General health. This will be measured in all patients at 6 and 12 months after the shockroom admission using the EuroQol and HUI3 questionnaires; 4. All-cause mortality. This will include both in-hospital mortality and mortality during the first year following the trauma; 5. Radiation dose. The mean radiation dose will be calculated in both strategies based on the actual number and type of radiological examinations related to the initial trauma performed in each patient during the first year.

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Contacts

Public ContactJ.C. Goslings

Academic Medical Center (AMC), G4-105, P.O. Box 22660

j.c.goslings@amc.uva.nl+31 (0)20 5666019

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)