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Trial registered on ANZCTR


Registration number
ACTRN12616001145493
Ethics application status
Approved
Date submitted
1/08/2016
Date registered
23/08/2016
Date last updated
23/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of High Flow Tracheostomy Device for weaning from Mechanical Ventilation
Scientific title
Determination of the effect of a high flow tracheostomy device on applying positive airway pressure and increasing end expiratory lung volume in patients weaning from long term mechanical ventilation
Secondary ID [1] 289810 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Ventilation 299733 0
Tracheostomy 299734 0
Condition category
Condition code
Respiratory 299668 299668 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is 15 minutes of high flow oxygen treatment at 50L/min (intervention) via Highflow Trachesotomy interface (Optiflow (TM) Tracheostomy interface and MR850 heated humidifier, Fisher & Paykel Healthcare). All oxygen therapy will humidified as per standard practice. Patients will act as their own control. The order in which the intervention is applied will be randomised. A 15 minute washout period of standard low flow treatment will occur between the intervention and standard treatment. A registered ICU nurse with over 10 years experience will apply the interventions. The study will be conducted in the ICU of The Prince Charles Hospital. Oxygen saturation will be maintained at greater than 92% or as dictated by the treating intensivist. Electrical Impedance topography (EIT) will be used to measure end expiratory lung impedance (EELI) which correlates closely with end expiratory lung volume (EELV). EIT involves placing a belt containing sensors around the patients chest patients chest. A 6Fr cannula will be placed in the tracheostomy tube to 1cm from the proximal end. This will be conducted to a pressure transducer in order to measure airway pressures.
Intervention code [1] 295487 0
Treatment: Devices
Comparator / control treatment
The comparator treatment will be as per the intervention except that it will use a regular T-Piece weaning kit at flow rates of 15L/min. These flow rates are much lower then the intervention. All measurements will be the same Patients act as their own control group. Oxygen therapy in the control group was also humidified.
Control group
Active

Outcomes
Primary outcome [1] 299128 0
Changes in tracheal airway pressure as measured by a 6Fr cannula placed in the tracheostomy tube connected to a pressure transducer
Timepoint [1] 299128 0
At 15 minutes of standard treatment a 2 minute continuous reading will be undertaken. A further 2 minutes of continuous data will be collected at the end of 15 minutes of high flow therapy. A 15 minute washout period of standard treatment ( low flow) will be conducted between interventions
Primary outcome [2] 299129 0
Changes in EELV as measure by EELI using EIT
Timepoint [2] 299129 0
At 15 minutes of standard treatment a 2 minute continuous reading will be undertaken. A further 2 minutes of continuous data will be collected at the end of 15 minutes of high flow therapy. A 15 minute washout period of standard treatment ( low flow) will be conducted between interventions
Secondary outcome [1] 326275 0
Changes in respiratory rate as determined by EIT
Timepoint [1] 326275 0
At 15 minutes of standard treatment a 2 minute continuous reading will be undertaken. A further 2 minutes of continuous data will be collected at the end of 15 minutes of high flow therapy. A 15 minute washout period of standard treatment ( low flow) will be conducted between interventions
Secondary outcome [2] 326276 0
Changes in oxygenation as measured on arterial blood gas (ABG)
Timepoint [2] 326276 0
At 15 minutes of standard treatment an ABG will be taken. A further ABG will be collected at the end of 15 minutes of high flow therapy. A 15 minute washout period of standard treatment ( low flow) will be conducted between interventions
Secondary outcome [3] 326277 0
Changes in subjective dyspnoea score (modified Borg score)
Timepoint [3] 326277 0
At 15 minutes of standard treatment a modified Borg score will be undertaken. A further modified Borg score will be collected at the end of 15 minutes of high flow therapy. A 15 minute washout period of standard treatment ( low flow) will be conducted between interventions

Eligibility
Key inclusion criteria
Written informed consent
Male or female over 18 years of age
Tracheostomy in situ
Mechanical ventilation time over 96hrs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Patients unable to tolerate low flow oxygen as deemed by treating doctor
Pneumothorax

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)
Sealed Opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation using random nature of non study staff placing allocations in envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Patients will be placed on normal T-Piece weaning device for 15 minutes to establish baseline measurements and then randomly allocated to either a further 15 minutes on normal T-Piece device or 15 minutes on the high flow device. At the end of 15 minutes a 15 minute washout period will occur (on normal T-Piece device) followed by 15 minutes on the opposite treatment arm
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be reported using simple descriptive statistics and compared using either a paired t-test or Wilcoxon signed rank test as appropriate. The study will recruit 20 patients, No power calculation was performed for this study and this number is based on previous work we have carried out in post op cardiac surgical patients using high flow nasal prongs which showed statistically significant improved changes of similar parameters.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2013
Date of last participant enrolment
Anticipated
Actual
2/03/2015
Date of last data collection
Anticipated
Actual
2/03/2015
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6346 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 13889 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 294197 0
Charities/Societies/Foundations
Name [1] 294197 0
The Prince Charles Hospital Foundation
Country [1] 294197 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
The Prince Charles Hospital, 627 Rode Road, Chermside Qld 4320
Country
Australia
Secondary sponsor category [1] 293026 0
None
Name [1] 293026 0
Address [1] 293026 0
Country [1] 293026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295600 0
The Prince Charles Hospital Human Research Ethics Comitee
Ethics committee address [1] 295600 0
Ethics committee country [1] 295600 0
Australia
Date submitted for ethics approval [1] 295600 0
13/10/2011
Approval date [1] 295600 0
27/10/2011
Ethics approval number [1] 295600 0
HREC/11/QPCH/179

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67894 0
Ms Amanda Corley
Address 67894 0
Level 5 Clinical Sciences Building
The Prince Charles Hospital
Rode Rode
Chermside
Qld
4320
Country 67894 0
Australia
Phone 67894 0
+61 7 3139 5772
Fax 67894 0
Email 67894 0
amand.corley@health.qld.gov.au
Contact person for public queries
Name 67895 0
Amanda Corley
Address 67895 0
Level 5 Clinical Sciences Building
The Prince Charles Hospital
Rode Rode
Chermside
Qld
4320
Country 67895 0
Australia
Phone 67895 0
+61 7 3139 5772
Fax 67895 0
Email 67895 0
amand.corley@health.qld.gov.au
Contact person for scientific queries
Name 67896 0
Amanda Corley
Address 67896 0
Level 5 Clinical Sciences Building
The Prince Charles Hospital
Rode Rode
Chermside
Qld
4320
Country 67896 0
Australia
Phone 67896 0
+61 7 3139 5772
Fax 67896 0
Email 67896 0
amand.corley@health.qld.gov.au

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.