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Trial registered on ANZCTR


Registration number
ACTRN12613001216707
Ethics application status
Approved
Date submitted
17/10/2013
Date registered
5/11/2013
Date last updated
5/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial studying the effectiveness of mask ventilation with a 2 person method compared to the mask ventilation with a 1 person method in preterm neonates prior to non-emergent endotracheal intubation in reducing mask leak and airway obstruction
Scientific title
A randomised controlled trial studying the effectiveness of mask ventilation with a 2 person method compared to the mask ventilation with a 1 person method in preterm neonates prior to non-emergent endotracheal intubation in reducing mask leak and airway obstruction
Secondary ID [1] 283116 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mask leak and airway obstruction during mask ventilation in preterm neonates 289964 0
Condition category
Condition code
Respiratory 290335 290335 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mask ventilation with a 2 person method whereby one person holds the mask over the neonate's face with both hands and the second person provides the positive pressure breaths.
Duration of mask ventilation will be 5-10 minutes. It will be given once only. Endotracheal intubation will be performed immediately after mask ventilation has stabilised baby's oxygenation level. Follow up includes data collection from the monitors immediately after the intervention has concluded. There is no longer term follow up.
Intervention code [1] 287837 0
Treatment: Other
Comparator / control treatment
The intervention is being compared with the current standard 1 person method whereby that person holds the mask over the neonate's face with one hand and provides positive pressure breaths with the other hand.
Duration of mask ventilation will be 5-10 minutes. It will be given once only.
Control group
Active

Outcomes
Primary outcome [1] 290370 0
Mask leak
A respiratory function monitor [NM3 Respiratory Profile Monitor (Philips)] will be attached between the mask and the T piece resuscitator. It will collect data regarding inspired and expired tidal volume. Mask leak will be calculated as expired tidal volume x 100/inspired tidal volume.
Timepoint [1] 290370 0
After completing endotracheal intubation
Primary outcome [2] 290371 0
Airway obstruction
A respiratory function monitor [Respironics NM3 (Philips Healthcare, Netherlands)] will be attached between the mask and the T piece resuscitator. It will indicate patency of the airway during mask ventilation by showing expired carbon dioxide reading.
Timepoint [2] 290371 0
After completing endotracheal intubation
Primary outcome [3] 290372 0
Cerebral oxygenation
It will be assessed by using a near infra-red spectroscopy monitor (Nonin Medical Inc, Plymouth, Minnesota, USA). A probe will be applied to the scalp non-invasively to collect data regarding oxygenated and deoxygenated hemoglobin from which a reading of tissue oxygenation index will be derived.
Timepoint [3] 290372 0
After completing endotracheal intubation
Secondary outcome [1] 304369 0
Nil
Timepoint [1] 304369 0
Not applicable

Eligibility
Key inclusion criteria
1. Gestation less than 30 weeks
2. Undergoing non-emergent endotracheal intubation in the neonatal intensive care unit for any one of the following indications:
a. Recurrent episodes of apnoea
b. Rapidly rising oxygen requirement or oxygen requirement more than 40% on nasal continuous positive airway pressure of 8 cm H2O
c. Respiratory acidosis with pH less than 7.25 and PaCO2 more than 55 mm Hg
d. Increasing work of breathing such that in the opinion of the treating neonatologist, the neonate in likely to exhaust himself/herself
e. Large airway leak in an already intubated neonate where ongoing ventilation is required. A larger endotracheal tube will be inserted in this situation.
Minimum age
0 Hours
Maximum age
3 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neonates with lethal congenital anomalies
2. Neonates with upper airway anomalies
3. Intubation required urgently (cardiorespiratory instability)
4. Unavailability of the research team

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)
Informed parental consent taken from eligible neonates' parents. Randomisation cards sealed in opaque envelopes (one person vs two person mask ventilation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The website www.randomizer.org was used to generate the randomisation sequences. Randomisation is stratified according to gestation (23-26 weeks, 27-29 weeks).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size was calculated based on a previous manikin based study which had shown 50% reduction in mask leak with the two-person method as compared to the one-person method. Using a p value of 0.05, 80% power and 50% reduction in mask leak, we will require 28 patients in each group.
Univariate and multivariate regression with correction for repeated measures

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1596 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 7473 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 287967 0
Hospital
Name [1] 287967 0
Westmead Hospital
Address [1] 287967 0
Neonatal Intensive Care Unit
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country [1] 287967 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Neonatal Intensive Care Unit, Westmead Hospital
Darcy Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 286685 0
None
Name [1] 286685 0
Address [1] 286685 0
Country [1] 286685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289890 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 289890 0
Westmead Hospital
Darcy Rd
Westmead NSW 2145
Ethics committee country [1] 289890 0
Australia
Date submitted for ethics approval [1] 289890 0
Approval date [1] 289890 0
14/05/2013
Ethics approval number [1] 289890 0
HREC/12/WMEAD/194

Summary
Brief summary
Newborn intensive care provides life-saving mechanical ventilation when the lungs of a very ill baby deteriorate with illness and need assistance to provide blood oxygen and removal of blood carbon dioxide. This involves the routine placement of a soft plastic tube called an endotracheal tube into the main breathing passageway called the trachea. This tube is placed via the nose or the mouth and mediations are used to relax the baby to ensure the procedure occurs with minimal disturbance. With these medications, the medical staff will provide breaths with a mask placed over the mouth and nose. There are two recognized ways of holding the mask. In both methods some leak of the breath provided occurs around the mask and occasionally a degree of obstruction occurs. This study seeks to determine which method is better.

These methods are; where one person holds the mask in place with one hand and provides breaths with the other hand compared to the other method where one person holds the mask and another person provides the breaths.

The purpose is to investigate whether by using a two-person method for mask ventilation; we are able to reduce the leak and airway obstruction so that the ventilation is more effective.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 42554 0
Dr Mark Tracy
Address 42554 0
C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 42554 0
Australia
Phone 42554 0
+61298456568
Fax 42554 0
Email 42554 0
mark.tracy@swahs.health.nsw.gov.au
Contact person for public queries
Name 42555 0
Dr Rajesh Maheshwari
Address 42555 0
C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 42555 0
Australia
Phone 42555 0
+61298456386
Fax 42555 0
Email 42555 0
rajesh.maheshwari@swahs.health.nsw.gov.au
Contact person for scientific queries
Name 42556 0
Dr Rajesh Maheshwari
Address 42556 0
C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 42556 0
Australia
Phone 42556 0
+61298456386
Fax 42556 0
Email 42556 0
rajesh.maheshwari@swahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results