Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients
Primary Purpose
Critically Injured Mechanically Ventilated Trauma Patients
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Protective manual hyperinflation
Usual method of MHI
Sponsored by
About this trial
This is an interventional treatment trial for Critically Injured Mechanically Ventilated Trauma Patients focused on measuring Trauma
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
Sites / Locations
- Royal Brisbane & Womens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual method of MHI
Protective MHI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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.
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.
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
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
Full Information
NCT ID
NCT01366274
First Posted
May 31, 2011
Last Updated
June 3, 2011
Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01366274
Brief Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Injured Mechanically Ventilated Trauma Patients
Keywords
Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual method of MHI
Arm Type
Active Comparator
Arm Title
Protective MHI
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Protective manual hyperinflation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual method of MHI
Intervention Description
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
Primary Outcome Measure Information:
Title
Interleukin 6
Description
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
Time Frame
Change between Baseline and 40 minutes and 70 minutes post baseline
Secondary Outcome Measure Information:
Title
Tumour necrosis factor alpha
Description
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
Time Frame
Change from Baseline to 40 minutes and 70 minutes post baseline
Title
Interleukin 1-beta
Description
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
Time Frame
Change between baseline and 40 minutes and 70 minutes post baseline
Title
Interleukin 8
Description
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
Time Frame
Change between baseline and 40 minutes and 70 minutes post baseline
Title
PaO2/FiO2 Oxygenation ratio
Description
The ratio between the partial pressure of oxygen in arterial blood and the fraction of inspired oxygen which is delivered to the patient.
Time Frame
Chnge between baseline and 15 minutes and 40 minutes post baseline
Title
Static lung compliance
Description
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.
Time Frame
Change between Baseline and 15 minutes and 70 minutes post baseline
Title
Mean arterial blood pressure
Description
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
Time Frame
the change between baseline and every minute during intervention for 10 minutes will be compared
Title
Sputum volume
Description
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
Time Frame
Immediately at end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Royal Brisbane & Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
12. IPD Sharing Statement
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Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients
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