Overview

This trial is active, not recruiting.

Condition critically injured mechanically ventilated trauma patients
Treatments protective manual hyperinflation, usual method of mhi
Sponsor The University of Queensland
Collaborator Royal Brisbane and Women's Hospital
Start date September 2007
End date December 2011
Trial size 40 participants
Trial identifier NCT01366274, PMH1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
usual 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
(Experimental)
protective 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

Primary Outcomes

Measure
Interleukin 6
time frame: Change between Baseline and 40 minutes and 70 minutes post baseline

Secondary Outcomes

Measure
Tumour necrosis factor alpha
time frame: Change from Baseline to 40 minutes and 70 minutes post baseline
Interleukin 1-beta
time frame: Change between baseline and 40 minutes and 70 minutes post baseline
Interleukin 8
time frame: Change between baseline and 40 minutes and 70 minutes post baseline
PaO2/FiO2 Oxygenation ratio
time frame: Chnge between baseline and 15 minutes and 40 minutes post baseline
Static lung compliance
time frame: Change between Baseline and 15 minutes and 70 minutes post baseline
Mean arterial blood pressure
time frame: the change between baseline and every minute during intervention for 10 minutes will be compared
Sputum volume
time frame: Immediately at end of intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by The University of Queensland.