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Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The University of Queensland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Royal Brisbane and Women's Hospital
Information provided by:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT01366274
First received: May 31, 2011
Last updated: June 3, 2011
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Critically Injured Mechanically Ventilated Trauma Patients
 Other: Protective manual hyperinflation
Other: Usual method of MHI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by The University of Queensland:

Primary Outcome Measures:
  • Interleukin 6 [ Time Frame: Change between Baseline and 40 minutes and 70 minutes post baseline ] [ Designated as safety issue: No ]
    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:
  • Tumour necrosis factor alpha [ Time Frame: Change from Baseline to 40 minutes and 70 minutes post baseline ] [ Designated as safety issue: No ]
    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

  • Interleukin 1-beta [ Time Frame: Change between baseline and 40 minutes and 70 minutes post baseline ] [ Designated as safety issue: No ]
    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

  • Interleukin 8 [ Time Frame: Change between baseline and 40 minutes and 70 minutes post baseline ] [ Designated as safety issue: No ]
    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

  • PaO2/FiO2 Oxygenation ratio [ Time Frame: Chnge between baseline and 15 minutes and 40 minutes post baseline ] [ Designated as safety issue: No ]
    The ratio between the partial pressure of oxygen in arterial blood and the fraction of inspired oxygen which is delivered to the patient.

  • Static lung compliance [ Time Frame: Change between Baseline and 15 minutes and 70 minutes post baseline ] [ Designated as safety issue: No ]

    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.


  • Mean arterial blood pressure [ Time Frame: the change between baseline and every minute during intervention for 10 minutes will be compared ] [ Designated as safety issue: Yes ]
    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

  • Sputum volume [ Time Frame: Immediately at end of intervention ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Jennifer Paratz, University of Queensland
ClinicalTrials.gov Identifier: NCT01366274     History of Changes
Other Study ID Numbers: PMH1
Study First Received: May 31, 2011
Last Updated: June 3, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of Queensland:
Trauma

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013