Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients

Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Critically Injured Mechanically Ventilated Trauma Patients
• Intervention / Treatment: Other: Usual method of MHI; Other: Protective manual hyperinflation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane & Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual method of MHI	Other: 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 MHI	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Royal Brisbane and Women's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 3, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PMH1