Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000579493
Ethics application status
Approved
Date submitted
7/11/2007
Date registered
9/11/2007
Date last updated
11/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Respiratory management of acute cervical spinal cord injury with non-invasive ventilation
Scientific title
Cervical spinal cord injured patients American spinal injuries association (ASIA) classification A, B or C complete. Respiratory management with prophylactic non invasive ventilation compared to standard respiratory management. Intensive care unit length of stay outcome.
Secondary ID [1] 262149 0
NIV in acute SCI
Universal Trial Number (UTN)
Trial acronym
NIVSCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 2529 0
Condition category
Condition code
Respiratory 2629 2629 0 0
Other respiratory disorders / diseases
Neurological 2633 2633 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute cervical spinal cord injury ASIA A, B and C managed with prophylactic non invasive ventilation over the first 120 hours since onset of injury.
Intervention code [1] 2262 0
Treatment: Devices
Comparator / control treatment
Standard respiratory management over the first 120 hours since admission.
Control group
Active

Outcomes
Primary outcome [1] 3538 0
Vital capacity measured by calibrated wrights spirometer in supine, best of three attempts.
Timepoint [1] 3538 0
4 and 7 days post injury
Primary outcome [2] 3539 0
Length of stay in intensive care unit (ICU)
Timepoint [2] 3539 0
Eligibility to be discharged from ICU to spinal ward
Secondary outcome [1] 5918 0
length of mechanical ventilation
Timepoint [1] 5918 0
discharge from ICU
Secondary outcome [2] 5919 0
Incidence of tracheostomy
Timepoint [2] 5919 0
discharge from ICU
Secondary outcome [3] 5920 0
incidence of pneumonia
Timepoint [3] 5920 0
discharge from ICU

Eligibility
Key inclusion criteria
Acute cervical spinal cord injury ASIA A, B or C.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-admit to spinal centre >24 hours post injury -surgical management of cervical spine injury elsewhere -total brain injury -unable to provide consent -non invasive ventilation contraindicated -ventilated on arrival to primary spinal centre.

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)
-all admitted patients screened for eligibility.
-allocated to treatment or control via sequentially numbered, opaque sealed envelopes by a person not directly invoved in trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers used to generate allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 484 0
2065

Funding & Sponsors
Funding source category [1] 2769 0
Hospital
Name [1] 2769 0
Royal North Shore Hospital
Country [1] 2769 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital research office
Address
Pacific HWY
St Leonards NSW
2065
Country
Australia
Secondary sponsor category [1] 2502 0
Hospital
Name [1] 2502 0
RNSH spinal research fund
Address [1] 2502 0
Spinal Cord Injuries Unit
Level 7
Pacific Hwy
St Leonards
NSW
2065
Country [1] 2502 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4691 0
Northern Sydney Central Coast Health HREC
Ethics committee address [1] 4691 0
Level 4
Vindin House
Pacific HWY
St Leonards NSW
2065
Ethics committee country [1] 4691 0
Australia
Date submitted for ethics approval [1] 4691 0
01/11/2006
Approval date [1] 4691 0
30/12/2006
Ethics approval number [1] 4691 0
EC00333

Summary
Brief summary
Trail to start at RNSH but plans to become multi-centre involving spinal specialist units in Australia and New Zealand
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28165 0
Address 28165 0
Country 28165 0
Phone 28165 0
Fax 28165 0
Email 28165 0
Contact person for public queries
Name 11322 0
Damien Barratt
Address 11322 0
Level 7 main building
spinal physiotherapy RNSH
Pacific Hwy
St Leonards
NSW
2065
Country 11322 0
Australia
Phone 11322 0
02 99268783
Fax 11322 0
Email 11322 0
[email protected]
Contact person for scientific queries
Name 2250 0
Damien Barratt
Address 2250 0
Level 7 main building
spinal physiotherapy
RNSH
Pacific Hwy
St Leonards
NSW
2065
Country 2250 0
Australia
Phone 2250 0
02 9926 8783
Fax 2250 0
Email 2250 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.