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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
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Injured Mechanically Ventilated Trauma Patients focused on measuring Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 31, 2011
Last Updated
June 3, 2011
Sponsor
The University of Queensland
Collaborators
Royal Brisbane and Women's Hospital
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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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