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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Respiratory

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]

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]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [1]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [2]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [3]

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]

Measurement will taken at the time positive pressure ventilation is administered

Secondary outcome [4]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [5]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [6]

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]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [7]

Number of attempts of repositioning of the mask

Timepoint [7]

Measurements will be taken at the time positive pressure ventilation is administered

Secondary outcome [8]

Duration of positive pressure ventilation

Timepoint [8]

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?

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]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council Program Grant

Address [1]

National Health and Medical Research Council
16 Marcus Clarke Street
Canberra
ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

The Royal Women's Hospital 
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/02/2014

Approval date [1]

25/03/2014

Ethics approval number [1]

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

Dr Lorraine McGrory

Address

The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052

Country

Australia

Phone

+61 (0)3 83453776

Fax

[email protected]

Contact person for public queries

Name

Lorraine McGrory

Address

The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052

Country

Australia

Phone

+61 (0)3 83453776

Fax

[email protected]

Contact person for scientific queries

Name

Lorraine McGrory

Address

The Royal Women's Hospital
Cnr Grattan Street and Flemington Road
Parkville
Victoria
3052

Country

Australia

Phone

+61 (0)3 83453776

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Time to desaturation in preterm infants undergoing endotracheal intubation.	2021	https://dx.doi.org/10.1136/archdischild-2020-319509

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically