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Trial registered on ANZCTR


Registration number
ACTRN12613000940774
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
26/08/2013
Date last updated
29/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of 2 modes of non-invasive ventilation applied on patients after extubation
Scientific title
Noninvasive ventilation-neurally adjusted ventilatory assist (NIV-NAVA) compared to noninvasive ventilation-pressure support (NIV-PS) in post-extubated subjects on synchrony and work of breathing
Secondary ID [1] 283038 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure 289873 0
Condition category
Condition code
Respiratory 290234 290234 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
use of non-invasive ventilation in the neurally adjusted ventilatory assist mode (NIV-NAVA) with PEEP set at 5 cmH2O. NAVA gain level will be titrated to achieve an equivalent peak inspiratory pressure as in PSV (NAVA0). Another 2 levels will be set at 0.5 cmH2O/uV above and below NAVA0 (NAVA+1 and NAVA-1 respectively). Inspiratory trigger Edi will be set at 0.5uV above Edi min, while expiratory trigger is fixed by the manufacturer at 70% of Edi peak. The subject will breathe at each setting for 20 minutes as wash-out and recordings are obtained in the next 2 minutes.
Intervention code [1] 287758 0
Treatment: Devices
Comparator / control treatment
non-invasive ventilation in the pressure support mode (NIV-PS) with PEEP set at 5 cmH2O, PS titrated to achieve a tidal volume of 6-8ml/kg, inspiratory flow trigger at 5, expiratory trigger at 30% of maximal peak flow, rise time at 0.1 ms. The subject will breathe at this setting for 20 minutes and recordings are obtained in the next 2 minutes
Control group
Active

Outcomes
Primary outcome [1] 290255 0
% of patient-ventilator asynchrony index will be measured by studying airway pressure, flow (obtained using the Servo Tracker software) and esophageal pressure tracings measured using a balloon esophageal catheter, an analog-to-digital converter system and Labview software.
Timepoint [1] 290255 0
at the end of 20 minutes on each NIV setting
Primary outcome [2] 290256 0
inspiratory work of breathing will be measured using the diagram method of Campbell by integrating the area plotted between the esophageal pressure-volume and chestwall compliance curves. Esophageal pressure-time-product will also be calculated.
Timepoint [2] 290256 0
measured at the end of 20 minutes of each NIV setting
Secondary outcome [1] 304215 0
patient's comfort score assessed by a visual analog scale
Timepoint [1] 304215 0
measured at the end of 20 minutes on each NIV setting

Eligibility
Key inclusion criteria
1. Are currently or previously on mechanical ventilation for acute respiratory failure
2. Are considered fit for extubation (defined as hemodynamic stability without the need for vasopressor support and a heart rate less than 110 beats per minute (bpm), respiratory rate less than 30 per minutes, and a Glasgow coma scale of E4VtM6), or has been extubated already
3. Are indicated for NIV with >=1 of the risk factors for reintubation, including: chronic heart failure, COPD initially intubated because of an episode of acute hypercapnic respiratory failure, age >65, more than one consecutive failure of weaning trial before extubation, PaCO2 >45 mmHg (6 kPa) after extubation, weak cough
4. Expected to require NIV for >=2 days
5. Able to give consent to the study by him/herself.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients less than 18 years of age, pregnancy, with contraindications for insertion of nasogastric tube, or with contraindications for NIV (esophageal varices or obstruction, bleeding of the upper gastrointestinal tract, recent gastroesophageal surgery, hemodynamic instability or severe arrhythmia, facial surgery or trauma or deformity, severe upper airway obstruction, inability to cooperate or protect the airways, inability to cough or clear respiratory secretions, absence of a gag reflex and severe gastric distention), or contraindications to NAVA mode (known or suspected phrenic nerve dysfunction, and impaired respiratory drive).

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)
This is a cross-over study. After extubation, each subject will receive NIV in both NAVA and PS modes but in a random sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
4 pieces of paper labelled as PS mode, NAVA0, NAVA-1 and NAVA+1 are folded and placed inside a paper bag. The sequence of NIV levels per subject is determined by the sequence of paper drawn from the paper bag.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Prior studies provided only non-parametric data. Reduction in the median asynchrony index using NIV-NAVA compared to NIV-PS was 10.9% (from 15.8% (interquartile range, IQR 5.5-49.6%) to 4.9% (IQR 2.5 – 10.5 %) using data from Piquilloud et al 2012. With an estimated standard deviation of 13, a power of 90% and an alpha error of 5%, and using paired t test, the sample size calculated is 17.
Results will be presented as mean +/- SD. Comparisons between NIV-PS and NIV-NAVA will be done using the Mann-Whitney U test. P values of 0.05 or less will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
16/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment outside Australia
Country [1] 5315 0
Hong Kong
State/province [1] 5315 0

Funding & Sponsors
Funding source category [1] 287801 0
Hospital
Name [1] 287801 0
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital
Country [1] 287801 0
Hong Kong
Primary sponsor type
Hospital
Name
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital
Address
3 Lok Man Road, Chai Wan, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 286530 0
None
Name [1] 286530 0
Address [1] 286530 0
Country [1] 286530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289748 0
Hong Kong East Cluster Ethics Committee
Ethics committee address [1] 289748 0
Ethics committee country [1] 289748 0
Hong Kong
Date submitted for ethics approval [1] 289748 0
16/08/2013
Approval date [1] 289748 0
16/10/2013
Ethics approval number [1] 289748 0

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

Contacts
Principal investigator
Name 42234 0
Dr LAM Sin-Man
Address 42234 0
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan
Country 42234 0
Hong Kong
Phone 42234 0
852-25957133
Fax 42234 0
Email 42234 0
lamsm2@ha.org.hk
Contact person for public queries
Name 42235 0
LAM Sin-Man
Address 42235 0
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan
Country 42235 0
Hong Kong
Phone 42235 0
852-25957133
Fax 42235 0
Email 42235 0
lamsm2@ha.org.hk
Contact person for scientific queries
Name 42236 0
LAM Sin-Man
Address 42236 0
Department of Intensive Care, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan
Country 42236 0
Hong Kong
Phone 42236 0
852-25957133
Fax 42236 0
Email 42236 0
lamsm2@ha.org.hk

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.