Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study

Not Applicable

Recruiting

• Conditions: Neonatal Intensive Care

• Registration Number: NCT06740344
• Lead Sponsor: University College Dublin

Brief Summary

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor. Both types of mask holds are recommended in international guidelines, but it is unclear which one is better for the baby. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that the healthcare providers are trying to give. There currently is not enough evidence to say which type of hold is better to reduce this potential leaking of air.

In this study, the investigators will compare two different ways of holding a mask on a baby's face to help them breathe. Each baby will be randomly allocated to either a one-handed or a two-handed mask hold, and the investigators will measure how much air leaks out around the mask during each breath. Any baby in the neonatal unit may be included in this study.

Detailed Description

This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.

The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold as the control.

The population that will be studied is neonates in the neonatal intensive care unit (NICU), at any gestation, who the clinical team have decided to intubate.

A member of the research team, who will provide an out-of-hours on call service, will attend the event. The relevant outcomes will be measured by the Monivent Neo100, which will be set up by the research team. Standardised masks, as used per local protocol, will be used, with the sensor module placed between that and the T-piece with an adaptor.

The outcomes will assess the effectiveness of both the intervention and control, including ventilation parameters recorded by the Monivent Neo100 and the clinical stability of the patient. The primary outcome of this study is the percentage mask leak.

A research team member will record data for primary and secondary outcome. The event will be filmed for post-hoc video analysis.

The outcome assessor will be blinded to the group allocation.

This research project will take place over 24 months, with an interim analysis to ensure recruitment is projected to achieve sample size.

Study Timeline

• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Study Start: 2025-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication and who require mask ventilation prior to intubation attempt.

Exclusion Criteria

• Neonates with a congenital malformation that would impact mask seal will not be included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mask leak	Over a maximum of 20 minutes	Mask leak percentage, as measured by the Monivent Respiratory Function Monitor (RFM).; Collected over a minimum of 5 breaths. Maximum of 2 episodes of facemask ventilation will be collected, with values averaged.

Secondary Outcome Measures

Name	Time	Method
Lowest oxygen saturation	Over a maximum of 20 minutes	Lowest oxygen saturation detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.
Highest supplemental FiO2 used during facemask ventilation	Over a maximum of 20 minutes	Highest percentage FiO2 used during the period of facemask ventilation, as indicated by the set dial on the Neopuff.
Positive inspiratory pressure during facemask ventilation	Over a maximum of 20 minutes	Positive inspiratory pressure used during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.
Percentage of obstructed breaths during facemask ventilation	Over a maximum of 20 minutes	Percentage of obstructed breaths during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.
Tidal volume during facemask ventilation	Over a maximum of 20 minutes	Measured tidal volume during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.
Number of times facemask position is adjusted during facemask ventilation	Over a maximum of 20 minutes	Number of times clinical team needs to adjust mask position during the period of facemask ventilation.
Duration of facemask ventilation	Over a maximum of 20 minutes	Time duration of facemask ventilation
Crossover to other handhold	Over a maximum of 20 minutes	If allocated two-handed hold: Number of times clinical team elect to switch to one-handed hold.; If allocated one-handed hold: Number of times clinical team elect to switch to two-handed hold.
User opinion of mask hold	Over a maximum of 20 minutes	Survey of operator opinions about mask hold used, and their usual preference.
Lowest heart rate	Over a maximum of 20 minutes	Lowest heart rate detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.

Trial Locations

Locations (1)

The National Maternity Hospital Dublin; 🇮🇪 Dublin, Leinster, Ireland