Table 4.
Trial outcomes
| Intervention category | Primary outcome(s) | Measurement | Timing | Proportion included in analysis % Median (IQR) |
|---|---|---|---|---|
| Fluid therapy (n = 7) |
- Mortality and morbidity (n = 1) - Survival (n = 1) |
- Mortality – patients who died during follow up period (n = 1) - Morbidity – postal questionnaire; Short Form with 36 items (SF-36) (n = 1) - Survival (n = 1) |
- 28 days after injury (n = 1) - 6 months after injury (n = 1) |
98.6% (68.2 – 99.8) |
| - Recovery after bran injury (n = 2) | - Glasgow Outcome Score – Extended; 8-point scale (n = 2) | - 6 months after injury (n = 2) | ||
| - Incidence of Acute respiratory distress syndrome (ARDS) (n = 1) | - Presence of ARDS; based on American-European Consensus Conference on ARDS definition | - 28 days after injury | ||
| - Early crystalloid volume (n = 1) | - Defined as crystalloid infused from EMS arrival until end of study period | - 28 days after injury | ||
| - Blood pressure (n = 1) | - Systolic blood pressure in mmHg | - Admission to hospital | ||
| Analgesia (n = 7) | - Pain (n = 1) | - Pain intensity; verbal rating scale (0 none to 3 severe) | - 40 min after intervention |
99.7% (96.3 – 100) (Based on 6 reporting studies) |
| - Pain and anxiety (n = 1) | - 100-mm visual analogue scale (VAS) (0 no pain or no anxiety and 100 maximum pain or maximum anxiety) | - Arrival at hospital | ||
| - Pain (n = 1) | - Verbal numerical rating (0 no pain to 10 worst pain imaginable) | - Arrival at hospital | ||
| - Pain (n = 1) | - Tenderness measured by calibrated callipers in area of 1cm2 at the centre of injured area (marked on patient’s skin), measured between time of injury and 3 h thereafter | - 7 days after injury | ||
| - Pain (n = 2) | - Numeric rating scale (pain relief defined as 3 or lower of 10) (n = 2) |
- 15 min after intervention (n = 1) - Arrival at hospital (n = 1) |
||
| - Pain (n = 1) | - Presence of pain; Yes or No | - 2 days after injury | ||
| Blood product (n = 3) | - Mortality (n = 3) | - Mortality – patients who died during follow up period |
- 28 days after injury (n = 1) - 30 days after injury (n = 2) |
93.8% (N/A) |
| Temperature management (n = 3) | - Recovery after brain injury (n = 1) | - Glasgow Outcome Score – Extended; 8-point scale | - 6 months after injury | 100% (N/A) |
| - Body core temperature, cold discomfort and vital signs (n = 1) |
- Temperature; closed ear canal temperature sensor (Smiths Medical, Ltd., UK) - Cold discomfort; numerical rating scale (0 no cold to 10 unbearable cold), very cold to hot - Vital signs; routine EMS equipment |
- Arrival at hospital | ||
| - Improved patient satisfaction and reduced thermal discomfort, pain, and fear (n = 1) |
- Satisfaction; rating scale (very good to unacceptable) - Pain; numerical rating scale (0 no pain to 5 worst imaginable pain) - Fear; rating scale (no, mild or severe anxiety) |
- Arrival at hospital | ||
| Airway management/ventilation (n = 2) | - Recovery after brain injury (n = 1) | - Glasgow Outcome Score – Extended; 8-point scale | - 6 months after injury | 74.45% (N/A) |
| - PaCO2 values as a marker of the adequacy of ventilation (n = 1) | - PaCO2 between 35 and 45 mmHg; (i-STAT, Hewlett Packard, Böblingen, Germany) | - Arrival at hospital | ||
| Model of care (n = 1) | - Recovery after brain injury (n = 1) | - Glasgow Outcome Score; 5-point scale | - 6 months after injury | 95.6% |