Critically Injured Mechanically Ventilated Trauma Patients Clinical Trial
Official title:
Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
| Verified date | November 2010 |
| Source | The University of Queensland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Australia: Human Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Brisbane & Womens Hospital | Brisbane | Queensland |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Queensland | Royal Brisbane and Women's Hospital |
Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Interleukin 6 | 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 | Change between Baseline and 40 minutes and 70 minutes post baseline | No |
| Secondary | Tumour necrosis factor alpha | 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 | Change from Baseline to 40 minutes and 70 minutes post baseline | No |
| Secondary | Interleukin 1-beta | 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 | Change between baseline and 40 minutes and 70 minutes post baseline | No |
| Secondary | Interleukin 8 | 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 | Change between baseline and 40 minutes and 70 minutes post baseline | No |
| Secondary | PaO2/FiO2 Oxygenation ratio | The ratio between the partial pressure of oxygen in arterial blood and the fraction of inspired oxygen which is delivered to the patient. | Chnge between baseline and 15 minutes and 40 minutes post baseline | No |
| Secondary | Static lung compliance | 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. |
Change between Baseline and 15 minutes and 70 minutes post baseline | No |
| Secondary | Mean arterial blood pressure | 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 | the change between baseline and every minute during intervention for 10 minutes will be compared | Yes |
| Secondary | Sputum volume | 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 | Immediately at end of intervention | No |