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Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients

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ClinicalTrials.gov Identifier: NCT01366274
Recruitment Status : Unknown
Verified November 2010 by The University of Queensland.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Critically Injured Mechanically Ventilated Trauma Patients Other: Protective manual hyperinflation Other: Usual method of MHI

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
Study Start Date : September 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Interleukin 6 [ Time Frame: 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 Outcome Measures :
  1. Tumour necrosis factor alpha [ Time Frame: 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

  2. Interleukin 1-beta [ Time Frame: 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

  3. Interleukin 8 [ Time Frame: 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

  4. PaO2/FiO2 Oxygenation ratio [ Time Frame: 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.

  5. Static lung compliance [ Time Frame: 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.


  6. Mean arterial blood pressure [ Time Frame: 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

  7. Sputum volume [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366274


Locations
Australia, Queensland
Royal Brisbane & Womens Hospital
Brisbane, Queensland, Australia, 4029
Sponsors and Collaborators
The University of Queensland
Royal Brisbane and Women's Hospital
More Information

Responsible Party: Dr Jennifer Paratz, University of Queensland
ClinicalTrials.gov Identifier: NCT01366274     History of Changes
Other Study ID Numbers: PMH1
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: November 2010

Keywords provided by The University of Queensland:
Trauma

Additional relevant MeSH terms:
Wounds and Injuries