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 obstructio

Not Applicable

Recruiting

• Conditions: Mask leak and airway obstruction during mask ventilation in preterm neonates; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12613001216707
• Lead Sponsor: Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mask leak<br>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.[After completing endotracheal intubation];Airway obstruction<br>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.[After completing endotracheal intubation];Cerebral oxygenation<br>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.[After completing endotracheal intubation]

Secondary Outcome Measures

Name	Time	Method
il[Not applicable]