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Trial registered on ANZCTR


Registration number
ACTRN12616000542493
Ethics application status
Approved
Date submitted
22/04/2016
Date registered
27/04/2016
Date last updated
27/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of the use of a respiratory function monitor to teach
neonatal mask ventilation to healthcare professionals in a simulation setting
Scientific title
A randomised controlled trial of the use of a respiratory function monitor to teach
neonatal mask ventilation to healthcare professionals in a simulation setting
Secondary ID [1] 289068 0
none
Universal Trial Number (UTN)
U1111-1182-2232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal resuscitation 298514 0
Condition category
Condition code
Reproductive Health and Childbirth 298595 298595 0 0
Complications of newborn
Public Health 298622 298622 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Training in mask ventilation will be conducted according to the Newborn Resuscitation (NeoResus) program with the addition of a Respiratory Function Monitor (RFM) attached to the t- piece device (Neopuff). This will provide continuous real time feedback on mask leak. Course participants will perform the mask ventilation skill station in groups of six. Neonatal mask ventilation training will last for 1 hour and 25 minutes in total. During this time period each participant will perform two episodes of mask ventilation, each lasting 90 seconds. The first episode will consist of the participant performing mask ventilation as a standalone skill. The second episode will consist of the participant performing mask ventilation as part of a simulated resuscitation scenario. Participants will be instructed on mask ventilation and on interpretation of the RFM. When performing mask ventilation, the participants will be instructed to achieve:
1. Minimal (0-10%) mask leak, and
2. Mannequin chest rise
Both the participants and trainers will observe leak and chest rise during ventilation. Participants will adjust their technique to minimise the leak by making the following changes:
1. Reposition airway to the neutral position, avoid neck flexion or overextension
2. Mask adjustment: adjust face mask hold, ensure face mask is covering nose and mouth, ensure mask is pressed against mannequin face, adjust face mask position on face, reapply face mask
Participants will be advised of additional manoeuvers (suction mouth and nose, open mouth, increase pressure, consider an alternative airway) to attempt if they are unable to obtain chest rise and improvement in heart rate/colour and saturations in the simulation setting.

Quality assurance:

Supervision;
Each training course is supervised by 3-4 Nurse educators and 1-2 medical educators (Neonatal fellow and neonatal consultant or two neonatal fellows)

Measurement of participant adherence and compliance to teaching protocol;

Compliance with the standardisation of training and instruction will be ensured by facilitator instruction pre-course, assessment of facilitators, the use of checklists to assist facilitators, intermittent reassessment of each facilitator (6 monthly) and the presence of an independent researcher at each station, who is responsible for compliance with the study protocol i.e. timing of intervention, clarity and order of instruction. Compliance with the protocol will be recorded in each participant CRF.
Significant non-compliance is defined as a participant failing to perform two episodes of mask ventilation or performed mask ventilation for under 50% of the allocated time. Facilitators and researchers will be advised to report each incidence of significant non-compliance to the PI. A high number of non-compliance incidents will trigger a protocol review.

Assessment:
Immediately after the skill session, participants will be reassessed and mask leak will be recorded for 90 seconds of mask ventilation. This timeframe was chosen because international guidelines recommend operators re-assess the airway every 30 seconds and we wish to capture at least 2 reassessment episodes.


Intervention code [1] 294573 0
Treatment: Other
Comparator / control treatment
Training in mask ventilation will be conducted according to the Newborn Resuscitation (NeoResus) program with a T-piece device (Neopuff). Participants will perform the mask ventilation skill station in groups of six. Neonatal mask ventilation training will last for 1 hour and 25 minutes in total. During this time period each participant will perform two episodes of mask ventilation, each lasting 90 seconds. The first episode will consist of the participant performing mask ventilation as a standalone skill. The second episode will consist of the participant performing mask ventilation as part of a simulated resuscitation scenario.
Participants will be instructed on mask ventilation. When performing mask ventilation, the participants will be instructed to achieve adequate mannequin chest rise. Both the participants and trainers will observe chest rise during ventilation.
Participants will adjust their technique to improve chest rise by making the following changes:
1. Reposition airway to the neutral position, avoid neck flexion or overextension
2. Mask adjustment: adjust face mask hold, ensure face mask is covering nose and mouth, ensure mask is pressed against mannequin face, adjust face mask position on face, reapply face mask
Participants will be advised of additional manoeuvers (suction mouth and nose, open mouth, increase pressure, consider an alternative airway) to attempt if they are unable to obtain chest rise and improvement in heart rate/colour and saturations in the clinical setting.

Assessment:
Immediately after the skill session, participants will be reassessed and mask leak will be recorded for 90 seconds of mask ventilation. This timeframe was chosen because international guidelines recommend operators re-assess the airway every 30 seconds and we wish to capture at least 2 reassessment episodes.
Control group
Active

Outcomes
Primary outcome [1] 298097 0
The primary outcome is difference in leak measured after neonatal mask ventilation training between the control and intervention groups. Leak between the mask and the mannequin face will be measured. The 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.
Leak (%) = (inflating tidal volume - expired tidal volume     x100) / inflating tidal volume
A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow. The monitor measures flow directly through a line connected at the T-piece. Gas flow is measured using a flow sensor placed between the mask and the Neopuff. The monitor integrates the flow signal to determine the tidal volume of gas passing through the sensor.
Timepoint [1] 298097 0
Measure immediately after completion of 1 hour 25 minutes of training
Secondary outcome [1] 323169 0
Difference in expired tidal volume
A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow. The monitor measures flow directly through a line connected at the T-piece. Gas flow is measured using a flow sensor placed between the mask and the Neopuff. The monitor integrates the flow signal to determine the tidal volume of gas passing through the sensor.

Timepoint [1] 323169 0
Measured immediately after 1 hour 25 minutes of training
Secondary outcome [2] 323211 0
Stability of tidal volume achieved ie consistency of tidal volumes in consecutive breaths.
A Florian Respiratory Function monitor (Acutronic Medical Systems, Zug, Switzerland) will be used to measure inflating pressures and gas flow. The monitor measures flow directly through a line connected at the T-piece. Gas flow is measured using a flow sensor placed between the mask and the Neopuff. The monitor integrates the flow signal to determine the tidal volume of gas passing through the sensor.
Timepoint [2] 323211 0
Measured immediately after 1 hour 25 minutes of training
Secondary outcome [3] 323214 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. The monitor measures flow directly through a line connected at the T-piece. Gas flow is measured using a flow sensor placed between the mask and the Neopuff. The monitor integrates the flow signal to determine the tidal volume of gas passing through the sensor.
Timepoint [3] 323214 0
Measured immediately after 1 hour 25 minutes of training

Eligibility
Key inclusion criteria
Each participant must meet the following criteria to be enrolled in the study:
1. Over 18 years of age
2. One of the following healthcare professionals: Doctors from any specialty, midwives, nurses, physiotherapists, occupational therapists, paramedics, or a medical, nursing or midwifery student
3. Attending the Victorian Neonatal Resuscitation training program. Attendees of both the first response program (3 hours’ duration) and the Advanced Resuscitation (7 hours’ duration) are eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unable or unwilling to provide written informed consent
2. Attendees who are not one of the healthcare professional groups or student groups listed above will not be included

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using sequentially numbered, sealed opaque envelopes. Study envelopes will be kept in the Paediatric Infant Perinatal Emergency Retrieval (PIPER) Education office, Second floor, Royal Children’s Hospital, Parkville, VIC 3052, Australia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation

Mask leak has been reported between 14-65% in neonatal mannequin studies and 29% (interquartile range 16-63%) in preterm infant resuscitation studies. Assuming a median leak of 50% in the control group and a standard deviation of 30% a sample size of 382 (191 in each arm) would give a power of 90% to detect a 10% absolute difference in leak (50% leak versus 40% leak). Fourteen neonatal resuscitation courses are planned in the Royal Children’s Hospital, Melbourne in 2016 with 24 participants per course. We estimate that consent, equipment and availability of researchers will allow for 12 participants per course to be enrolled. We therefore expect to be able to complete recruitment in 27 months.

Statistical Analysis Plan

Analysis will be performed on an intention-to-treat basis. Data will be analysed using 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. Data will be clustered by operator. 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
12/05/2016
Actual
12/05/2016
Date of last participant enrolment
Anticipated
12/12/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
382
Accrual to date
262
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5680 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 8625 0
The Women’s at Sandringham - Sandringham
Recruitment hospital [3] 8626 0
Frankston Hospital - Frankston
Recruitment hospital [4] 8627 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 8628 0
The Northern Hospital - Epping
Recruitment hospital [6] 8629 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [7] 8630 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [8] 8631 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [9] 8632 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment hospital [10] 8633 0
Benalla Health - Benalla
Recruitment hospital [11] 8634 0
Djerriwarrh Health Service - Bacchus Marsh - Bacchus Marsh
Recruitment hospital [12] 8635 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [13] 8636 0
Castlemaine Health - Castlemaine
Recruitment hospital [14] 8637 0
Cohuna District Hospital - Cohuna
Recruitment hospital [15] 8638 0
Colac Area Health - Colac
Recruitment hospital [16] 8639 0
Echuca Regional Health - Echuca
Recruitment hospital [17] 8640 0
Epworth Freemasons - Melbourne
Recruitment hospital [18] 8641 0
Western District Health Service - Hamilton - Hamilton
Recruitment hospital [19] 8642 0
Gippsland Southern Health Service - Leongatha campus - Leongatha
Recruitment hospital [20] 8643 0
Maryborough Hospital - Maryborough
Recruitment hospital [21] 8644 0
The Bays Hospital - Mornington - Mornington
Recruitment hospital [22] 8645 0
West Gippsland Healthcare Group - Warragul
Recruitment hospital [23] 8646 0
Southwest Health Care - Warrnambool - Warrnambool
Recruitment hospital [24] 8647 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [25] 8648 0
Bass Coast Regional Health - Wonthaggi
Recruitment hospital [26] 8649 0
Kyneton District Health Service - Kyneton
Recruitment postcode(s) [1] 16733 0
3191 - Sandringham
Recruitment postcode(s) [2] 16734 0
3199 - Frankston
Recruitment postcode(s) [3] 16735 0
3144 - Malvern
Recruitment postcode(s) [4] 16736 0
3076 - Epping
Recruitment postcode(s) [5] 16737 0
3400 - Horsham
Recruitment postcode(s) [6] 16738 0
3844 - Traralgon
Recruitment postcode(s) [7] 16739 0
3677 - Wangaratta
Recruitment postcode(s) [8] 16740 0
3690 - Wodonga
Recruitment postcode(s) [9] 16741 0
3672 - Benalla
Recruitment postcode(s) [10] 16742 0
3340 - Bacchus Marsh
Recruitment postcode(s) [11] 16743 0
3220 - Geelong
Recruitment postcode(s) [12] 16744 0
3450 - Castlemaine
Recruitment postcode(s) [13] 16745 0
3568 - Cohuna
Recruitment postcode(s) [14] 16746 0
3250 - Colac
Recruitment postcode(s) [15] 16747 0
3564 - Echuca
Recruitment postcode(s) [16] 16748 0
3002 - Melbourne
Recruitment postcode(s) [17] 16749 0
3300 - Hamilton
Recruitment postcode(s) [18] 16750 0
3953 - Leongatha
Recruitment postcode(s) [19] 16751 0
4650 - Maryborough
Recruitment postcode(s) [20] 16752 0
3931 - Mornington
Recruitment postcode(s) [21] 16753 0
3820 - Warragul
Recruitment postcode(s) [22] 16754 0
3280 - Warrnambool
Recruitment postcode(s) [23] 16755 0
3030 - Werribee
Recruitment postcode(s) [24] 16756 0
3995 - Wonthaggi
Recruitment postcode(s) [25] 16757 0
3444 - Kyneton

Funding & Sponsors
Funding source category [1] 293445 0
Hospital
Name [1] 293445 0
Royal Women's Hospital
Country [1] 293445 0
Australia
Primary sponsor type
Hospital
Name
Centre for Research Excellence and Newborn Research Centre, Royal Women's Hospital Melbourne
Address
Royal Women's Hospital
20 Flemington rd,
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 292268 0
None
Name [1] 292268 0
Address [1] 292268 0
Country [1] 292268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294889 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 294889 0
Ethics committee country [1] 294889 0
Australia
Date submitted for ethics approval [1] 294889 0
24/03/2016
Approval date [1] 294889 0
06/04/2016
Ethics approval number [1] 294889 0
RCH HREC Reference Number: 36031A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 857 857 0 0
/AnzctrAttachments/370577-Protocol 21.03.16.docx
Attachments [2] 858 858 0 0
/AnzctrAttachments/370577-36031A HREC and Governance (06.04.2016).pdf

Contacts
Principal investigator
Name 65366 0
Dr Eoin O Currain
Address 65366 0
Newborn Research Centre
20 Flemington Rd
Royal Women's Hospital
Parkville
VIC 3052
Country 65366 0
Australia
Phone 65366 0
+61, 3, 83453763
Fax 65366 0
Email 65366 0
eoin.ocurrain@thewomens.org.au
Contact person for public queries
Name 65367 0
Eoin O Currain
Address 65367 0
Newborn Research Centre
20 Flemington Rd
Royal Women's Hospital
Parkville
VIC 3052
Country 65367 0
Australia
Phone 65367 0
+61, 3, 83453763
Fax 65367 0
Email 65367 0
eoin.ocurrain@thewomens.org.au
Contact person for scientific queries
Name 65368 0
Eoin O Currain
Address 65368 0
Newborn Research Centre
20 Flemington Rd
Royal Women's Hospital
Parkville
VIC 3052
Country 65368 0
Australia
Phone 65368 0
+61, 3, 83453763
Fax 65368 0
Email 65368 0
eoin.ocurrain@thewomens.org.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
SourceTitleYear of PublicationDOI
EmbaseRespiratory monitors to teach newborn facemask ventilation: A randomised trial.2019https://dx.doi.org/10.1136/archdischild-2018-316118
N.B. These documents automatically identified may not have been verified by the study sponsor.