Clinical trial NCT01366274: Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients
Official title: Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Injured Mechanically Ventilated Trauma Patients
Keywords: Trauma
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Royal Brisbane and Women's Hospital
First posted: 2011-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 6
timeFrame: Change between Baseline and 40 minutes and 70 minutes post baseline
Secondary outcomes:
measure: Tumour necrosis factor alpha
timeFrame: Change from Baseline to 40 minutes and 70 minutes post baseline
measure: Interleukin 1-beta
timeFrame: Change between baseline and 40 minutes and 70 minutes post baseline
measure: Interleukin 8
timeFrame: Change between baseline and 40 minutes and 70 minutes post baseline
measure: PaO2/FiO2 Oxygenation ratio
timeFrame: Chnge between baseline and 15 minutes and 40 minutes post baseline
measure: Static lung compliance
timeFrame: Change between Baseline and 15 minutes and 70 minutes post baseline
measure: Mean arterial blood pressure
timeFrame: the change between baseline and every minute during intervention for 10 minutes will be compared
measure: Sputum volume
timeFrame: Immediately at end of intervention
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane & Womens Hospital
state: Queensland
Study officials:
References: