ANZCTR - Registration

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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

Secondary ID [1]

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

Condition category

Condition code

Respiratory

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]

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]

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]

After completing endotracheal intubation

Primary outcome [2]

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]

After completing endotracheal intubation

Primary outcome [3]

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]

After completing endotracheal intubation

Secondary outcome [1]

Nil

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

21/05/2013

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]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Neonatal Intensive Care Unit
Westmead Hospital
Darcy Rd
Westmead NSW 2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Westmead Hospital
Darcy Rd
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/05/2013

Ethics approval number [1]

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

Dr Mark Tracy

Address

C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145

Country

Australia

Phone

+61298456568

Fax

mark.tracy@swahs.health.nsw.gov.au

Contact person for public queries

Name

Rajesh Maheshwari

Address

C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145

Country

Australia

Phone

+61298456386

Fax

rajesh.maheshwari@swahs.health.nsw.gov.au

Contact person for scientific queries

Name

Rajesh Maheshwari

Address

C/O Neonatal Intensive Care Unit
Westmead Hospital
PO Box 533
Wentworthville NSW 2145

Country

Australia

Phone

+61298456386

Fax

rajesh.maheshwari@swahs.health.nsw.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23290	Other
23815	Other

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.

Trial Review

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