Critically Injured Mechanically Ventilated Trauma Patients
Conditions
Keywords
Trauma
Brief summary
This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.
Detailed description
Current evidence in mechanical ventilation supports a protective lung strategy that is, smaller tidal volumes and prevention of loss of positive end expiratory pressure (PEEP). There is concern that manual hyperinflation (MHI) may conflict with this strategy and cause volutrauma and atelectrauma potentially leading to biotrauma. This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.
Interventions
OTHERProtective manual hyperinflation
Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 8mls/kg and positive end expiratory pressure in the circuit appropriate to baseline levels
OTHERUsual method of MHI
Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 12mls/kg and no positive end expiratory pressure in the circuit
Sponsors
Royal Brisbane and Women's Hospital
The University of Queensland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Trauma patients * Day 1 of admission to intensive care * Mechanically ventilated
Exclusion criteria
* Pre-existing lung disease * PEEP \> 12.5cmH20 * Nitric oxide in circuit * Haemodynamically unstable * Undrained pneumothorax * Intracranial pressure \> 25mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 6 | Change between Baseline and 40 minutes and 70 minutes post baseline | 5 mls of arterial blood will be colected in an EDTA tube, centrifuged and aliquoted within 30 minutes. It will be stored at -80 degrees C and the analysis completed in batches by enzyme linked immunosorbent assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 1-beta | Change between baseline and 40 minutes and 70 minutes post baseline | 5 mls of arterial blood will be colected in an EDTA tube, centrifuged and aliquoted within 30 minutes. It will be stored at -80 degrees C and the analysis completed in batches by enzyme linked immunosorbent assay |
| Interleukin 8 | Change between baseline and 40 minutes and 70 minutes post baseline | 5 mls of arterial blood will be colected in an EDTA tube, centrifuged and aliquoted within 30 minutes. It will be stored at -80 degrees C and the analysis completed in batches by enzyme linked immunosorbent assay |
| PaO2/FiO2 Oxygenation ratio | Chnge between baseline and 15 minutes and 40 minutes post baseline | The ratio between the partial pressure of oxygen in arterial blood and the fraction of inspired oxygen which is delivered to the patient. |
| Tumour necrosis factor alpha | Change from Baseline to 40 minutes and 70 minutes post baseline | 5 mls of arterial blood will be colected in an EDTA tube, centrifuged and aliquoted within 30 minutes. It will be stored at -80 degrees C and the analysis completed in batches by enzyme linked immunosorbent assay |
| Mean arterial blood pressure | the change between baseline and every minute during intervention for 10 minutes will be compared | The mean blood pressure will be recorded from the arterial catheter in situ. This is displayed continuously on the Phillips Intellivue Monitor and will be recorded for the time of intervention |
| Sputum volume | Immediately at end of intervention | Sputum will be suctioned at the end of the manual hyperinflation technique by an inline suction catheter using sterile technique into a closed sample jar. This will be weighed on an Acculab Pocket Scale PP401 |
| Static lung compliance | Change between Baseline and 15 minutes and 70 minutes post baseline | Static lung compliance is the change in volume for any given applied pressure. The formula is Compliance = Change in volume/change in pleural pressure. An inspiratory hold will be dialled on the mechanical ventilator and the static lung compliance value will be recorded from the screen. |
Countries
Australia
Outcome results
None listed