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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01366274




Registration number
NCT01366274
Ethics application status
Date submitted
31/05/2011
Date registered
6/06/2011
Date last updated
6/06/2011

Titles & IDs
Public title
Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients
Scientific title
Comparison of Protective Manual Hyperinflation With Current Methods in Ventilated Acute Trauma Patients: a Randomized Controlled Trial
Secondary ID [1] 0 0
PMH1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Injured Mechanically Ventilated Trauma Patients 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Protective manual hyperinflation
Other interventions - Usual method of MHI

Active Comparator: Usual method of MHI -

Experimental: Protective MHI -


Other interventions: 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

Other interventions: 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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Change between Baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Change from Baseline to 40 minutes and 70 minutes post baseline
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Change between baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Change between baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Chnge between baseline and 15 minutes and 40 minutes post baseline
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Change between Baseline and 15 minutes and 70 minutes post baseline
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
the change between baseline and every minute during intervention for 10 minutes will be compared
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Immediately at end of intervention

Eligibility
Key inclusion criteria
- Trauma patients

- Day 1 of admission to intensive care

- Mechanically ventilated
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-existing lung disease

- PEEP > 12.5cmH20

- Nitric oxide in circuit

- Haemodynamically unstable

- Undrained pneumothorax

- Intracranial pressure > 25mmHg

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Womens Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01366274
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01366274