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Trial registered on ANZCTR


Registration number
ACTRN12614000709640
Ethics application status
Approved
Date submitted
28/05/2014
Date registered
4/07/2014
Date last updated
20/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of different round masks for intermittent positive pressure ventilation in preterm infants prior to intubation
Scientific title
In preterm infants receiving mask ventilation prior to elective ventilation, does a mask with a diameter that approximates the distance from the top of the infant’s nose to the bottom of their chin compared to the standard mask reduce leak between the infant’s face and t-piece resuscitation device (Neopuff)
Secondary ID [1] 284306 0
nil
Universal Trial Number (UTN)
U1111-1154-8093
Trial acronym
The MASK study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 292041 0
Condition category
Condition code
Reproductive Health and Childbirth 291825 291825 0 0
Complications of newborn
Respiratory 292691 292691 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If mask ventilation is required prior to elective intubation, it will be performed using either the 35 or 42mm silicone Fisher & Paykel neonatal resuscitation masks. Infants less than 26 weeks post menstrual age will be allocated the 35mm mask and infants 27-32 weeks post menstrual age will be allocated the 42mm mask. The positive pressure ventilation will be performed by a Paediatric doctor.
Intervention code [1] 289477 0
Treatment: Devices
Comparator / control treatment
If mask ventilation is required prior to elective intubation, it will be performed using the Laerdal 0/0 silicone soft round mask which is the current standard of care at the Royal Women’s Hospital. The positive pressure ventilation will be performed by a Paediatric doctor.
Control group
Active

Outcomes
Primary outcome [1] 292238 0
Difference in leak measured between the mask and the infant’s face between the control and intervention groups.

A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes, and expiratory leak will be measured by the flow sensor. Expiratory leak will be calculated from the volume of gas that does not return back through the flow sensor on expiration, expressed as a percentage of the inspired volume.

Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures
Timepoint [1] 292238 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [1] 308509 0
Difference in tidal volumes.

A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes will be measured by the flow sensor.

Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures.
Timepoint [1] 308509 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [2] 308510 0
Percentage of obstructed breaths.

A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff. Tidal volumes will be measured by the flow sensor.


Spectra software (Grove Medical, London, UK) will record the leak, tidal volumes and delivered pressures. The percentage of breaths that are obstructed (where there is no or little tidal volume recorded) will be calculated from these recordings.
Timepoint [2] 308510 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [3] 308511 0
The infant’s lowest oxygen saturation during mask ventilation.

A pulse oximeter feeding data directly to spectra software (Grove Medical, London, UK) will be attached to the infant throughout the study and will be used to determine the infant’s changes in oxygen saturation.
Timepoint [3] 308511 0
Measurement will taken at the time positive pressure ventilation is administered
Secondary outcome [4] 308512 0
The infant’s lowest heart rate during mask ventilation

A pulse oximeter feeding data directly to spectra software (Grove Medical, London, UK) will be attached to the infant throughout the study and will be used to determine the infant’s changes in heart rate.
Timepoint [4] 308512 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [5] 308513 0
The highest inspired oxygen (FiO2) administered

A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) with an oxygen analyser will be used to measure the inspired oxygen concentration.

Spectra software (Grove Medical, London, UK) will record the inspired oxygen concentration.
Timepoint [5] 308513 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [6] 308514 0
Positive inspiratory pressure administered.

A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow via a flow sensor between the mask and the Neopuff.

Spectra software (Grove Medical, London, UK) will record the delivered pressures.
Timepoint [6] 308514 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [7] 308515 0
Number of attempts of repositioning of the mask
Timepoint [7] 308515 0
Measurements will be taken at the time positive pressure ventilation is administered
Secondary outcome [8] 308516 0
Duration of positive pressure ventilation
Timepoint [8] 308516 0
Measurements will be taken at the time positive pressure ventilation is administered

Eligibility
Key inclusion criteria
Inpatient preterm infants less than 33 weeks post menstrual age requiring mask intermittent positive pressure ventilation before an elective intubation attempt with premedication.
Minimum age
23 Weeks
Maximum age
32 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infants in the delivery room or operating theatre who require endotracheal intubation will not be eligible for entry to this study.

2. Infants with a congenital anomaly of their face which may affect the ability of a mask to create a seal will be excluded.

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)
Sequentially numbered, sealed, opaque envelopes containing the allocaton will be opened by the researcher just before mask positive pressure ventilation is administered.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by gestational age (<26 weeks and 27-32 weeks). Variable block randomisation will be used within each stratification group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of 20 infants were recently studied before elective intubation at the Royal Women’s Hospital (unpublished data). Mean leak was found to be 43.5% (SD 30%) Assuming a leak of 50% in the control group, a sample size 128 (64 in each arm) would give a power of 80% to detect a 15% absolute difference in leak between the groups (50% versus 35%)

Data will be analysed by Stata software (Intercooled 10, Stata Corp, College Station, Texas, USA). The data will be presented as mean (standard deviation) for normally distributed variables and median (interquartile range) when the distribution is skewed. The clinical characteristics and outcome variables will be analysed by using the Student t test for parametric and Mann-Whitney U test for nonparametric comparisons of continuous variables and Chi squared for categorical variables. P values will be 2-sided and P values of less than 0.05 will be considered statistically significant.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2516 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 8206 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 289312 0
Government body
Name [1] 289312 0
National Health and Medical Research Council Program Grant
Country [1] 289312 0
Australia
Primary sponsor type
Individual
Name
Dr Lorraine McGrory
Address
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 287983 0
None
Name [1] 287983 0
Address [1] 287983 0
Country [1] 287983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291075 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 291075 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052
Ethics committee country [1] 291075 0
Australia
Date submitted for ethics approval [1] 291075 0
19/02/2014
Approval date [1] 291075 0
25/03/2014
Ethics approval number [1] 291075 0
14/04

Summary
Brief summary
Preterm infants often need breathing support delivered through a mask placed on their faces (mask ventilation). Studies have shown that mask ventilation can be complicated by leak around the mask causing it to be less effective. Australian Resuscitation Council guidelines
state ‘the appropriate size of face mask must seal around the mouth and nose but not cover the eyes or overlap the chin.’ A standard 50mm diameter soft round silicon mask (Laerdal 0/0) has been the mask of choice historically used at the Royal Women’s Hospital. However a recent study has shown that a smaller mask may comply better with guidelines.
The aim of this study is to compare leak using a 50mm diameter mask compared to either 35mm (infants 26 weeks or less corrected gestational age) or 42mm ( 27 weeks or greater corrected gestational age) diameter masks (Fisher & Paykel neonatal resuscitation masks extra small or small).
The study is a randomised controlled trial. The population is preterm infants less than 33 weeks gestation who require intubation while inpatient in the neonatal intensive care unit. The term intubation refers to the insertion of a breathing or endotracheal tube into the infant’s airway, so that they can be supported by a ventilator. Before the insertion of the tube, the infant receives premedication that sedates and gives pain relief but will cause the infant to stop breathing necessitating a predictable period of mask ventilation. The intervention group will receive either the 35 or 42mm mask to deliver mask ventilation, the control group the 50mm mask. The primary outcome is the difference in leak measured between the mask and the infant’s face between control and intervention groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47126 0
Dr Lorraine McGrory
Address 47126 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052
Country 47126 0
Australia
Phone 47126 0
+61 (0)3 83453776
Fax 47126 0
Email 47126 0
[email protected]
Contact person for public queries
Name 47127 0
Lorraine McGrory
Address 47127 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052
Country 47127 0
Australia
Phone 47127 0
+61 (0)3 83453776
Fax 47127 0
Email 47127 0
[email protected]
Contact person for scientific queries
Name 47128 0
Lorraine McGrory
Address 47128 0
The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052
Country 47128 0
Australia
Phone 47128 0
+61 (0)3 83453776
Fax 47128 0
Email 47128 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
SourceTitleYear of PublicationDOI
EmbaseTime to desaturation in preterm infants undergoing endotracheal intubation.2021https://dx.doi.org/10.1136/archdischild-2020-319509
N.B. These documents automatically identified may not have been verified by the study sponsor.