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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Change between Baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [1] 0 0
Tumour necrosis factor alpha
Timepoint [1] 0 0
Change from Baseline to 40 minutes and 70 minutes post baseline
Secondary outcome [2] 0 0
Interleukin 1-beta
Timepoint [2] 0 0
Change between baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [3] 0 0
Interleukin 8
Timepoint [3] 0 0
Change between baseline and 40 minutes and 70 minutes post baseline
Secondary outcome [4] 0 0
PaO2/FiO2 Oxygenation ratio
Timepoint [4] 0 0
Chnge between baseline and 15 minutes and 40 minutes post baseline
Secondary outcome [5] 0 0
Static lung compliance
Timepoint [5] 0 0
Change between Baseline and 15 minutes and 70 minutes post baseline
Secondary outcome [6] 0 0
Mean arterial blood pressure
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
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
Sex
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2011
Actual
Sample size
Target
40
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
Government body
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01366274