Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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.
Query!
Secondary ID [1]
262149
0
NIV in acute SCI
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
NIVSCI
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
spinal cord injury
2529
0
Query!
Condition category
Condition code
Respiratory
2629
2629
0
0
Query!
Other respiratory disorders / diseases
Query!
Neurological
2633
2633
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
2262
0
Treatment: Devices
Query!
Comparator / control treatment
Standard respiratory management over the first 120 hours since admission.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
3538
0
Vital capacity measured by calibrated wrights spirometer in supine, best of three attempts.
Query!
Assessment method [1]
3538
0
Query!
Timepoint [1]
3538
0
4 and 7 days post injury
Query!
Primary outcome [2]
3539
0
Length of stay in intensive care unit (ICU)
Query!
Assessment method [2]
3539
0
Query!
Timepoint [2]
3539
0
Eligibility to be discharged from ICU to spinal ward
Query!
Secondary outcome [1]
5918
0
length of mechanical ventilation
Query!
Assessment method [1]
5918
0
Query!
Timepoint [1]
5918
0
discharge from ICU
Query!
Secondary outcome [2]
5919
0
Incidence of tracheostomy
Query!
Assessment method [2]
5919
0
Query!
Timepoint [2]
5919
0
discharge from ICU
Query!
Secondary outcome [3]
5920
0
incidence of pneumonia
Query!
Assessment method [3]
5920
0
Query!
Timepoint [3]
5920
0
discharge from ICU
Query!
Eligibility
Key inclusion criteria
Acute cervical spinal cord injury ASIA A, B or C.
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers used to generate allocation
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Date of first participant enrolment
Anticipated
15/10/2007
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
76
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment postcode(s) [1]
484
0
2065
Query!
Funding & Sponsors
Funding source category [1]
2769
0
Hospital
Query!
Name [1]
2769
0
Royal North Shore Hospital
Query!
Address [1]
2769
0
Pacific HWY
St Leonards NSW
2065
Query!
Country [1]
2769
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Royal North Shore Hospital research office
Query!
Address
Pacific HWY
St Leonards NSW
2065
Query!
Country
Australia
Query!
Secondary sponsor category [1]
2502
0
Hospital
Query!
Name [1]
2502
0
RNSH spinal research fund
Query!
Address [1]
2502
0
Spinal Cord Injuries Unit
Level 7
Pacific Hwy
St Leonards
NSW
2065
Query!
Country [1]
2502
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
4691
0
Northern Sydney Central Coast Health HREC
Query!
Ethics committee address [1]
4691
0
Level 4 Vindin House Pacific HWY St Leonards NSW 2065
Query!
Ethics committee country [1]
4691
0
Australia
Query!
Date submitted for ethics approval [1]
4691
0
01/11/2006
Query!
Approval date [1]
4691
0
30/12/2006
Query!
Ethics approval number [1]
4691
0
EC00333
Query!
Summary
Brief summary
Trail to start at RNSH but plans to become multi-centre involving spinal specialist units in Australia and New Zealand
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
28165
0
Query!
Address
28165
0
Query!
Country
28165
0
Query!
Phone
28165
0
Query!
Fax
28165
0
Query!
Email
28165
0
Query!
Contact person for public queries
Name
11322
0
Damien Barratt
Query!
Address
11322
0
Level 7 main building
spinal physiotherapy RNSH
Pacific Hwy
St Leonards
NSW
2065
Query!
Country
11322
0
Australia
Query!
Phone
11322
0
02 99268783
Query!
Fax
11322
0
Query!
Email
11322
0
[email protected]
Query!
Contact person for scientific queries
Name
2250
0
Damien Barratt
Query!
Address
2250
0
Level 7 main building
spinal physiotherapy
RNSH
Pacific Hwy
St Leonards
NSW
2065
Query!
Country
2250
0
Australia
Query!
Phone
2250
0
02 9926 8783
Query!
Fax
2250
0
Query!
Email
2250
0
[email protected]
Query!
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.
Download to PDF