Clinical trial NCT06740344: Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study
Official title: Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Intensive Care
Keywords: Neonatology
Facemask ventilation
Face mask ventilation
Mask hold
One-handed mask hold
One-handed hold
Mask leak
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mask leak
timeFrame: Over a maximum of 20 minutes
Secondary outcomes:
measure: Lowest oxygen saturation
timeFrame: Over a maximum of 20 minutes
measure: Highest supplemental FiO2 used during facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Positive inspiratory pressure during facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Percentage of obstructed breaths during facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Tidal volume during facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Number of times facemask position is adjusted during facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Duration of facemask ventilation
timeFrame: Over a maximum of 20 minutes
measure: Crossover to other handhold
timeFrame: Over a maximum of 20 minutes
measure: User opinion of mask hold
timeFrame: Over a maximum of 20 minutes
measure: Lowest heart rate
timeFrame: Over a maximum of 20 minutes
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The National Maternity Hospital Dublin
state: Leinster
Study officials:
References:
citation: Newborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021.
citation: Shah D, Tracy MB, Hinder MK, Badawi N. One-person versus two-person mask ventilation in preterm infants at birth: a pilot randomised controlled trial. BMJ Paediatr Open. 2023 Feb;7(1):e001768. doi: 10.1136/bmjpo-2022-001768.
citation: Tracy MB, Klimek J, Coughtrey H, Shingde V, Ponnampalam G, Hinder M, Maheshwari R, Tracy SK. Mask leak in one-person mask ventilation compared to two-person in newborn infant manikin study. Arch Dis Child Fetal Neonatal Ed. 2011 May;96(3):F195-200. doi: 10.1136/adc.2009.169847. Epub 2010 Nov 11.
citation: Murray A, Beechinor T, Livingstone V, Dempsey E. Two hands are better than one: Positive pressure ventilation in a preterm neonatal manikin model. Acta Paediatr. 2024 May;113(5):989-991. doi: 10.1111/apa.17156. Epub 2024 Feb 22. No abstract available.
citation: Wood FE, Morley CJ. Face mask ventilation--the dos and don'ts. Semin Fetal Neonatal Med. 2013 Dec;18(6):344-51. doi: 10.1016/j.siny.2013.08.009. Epub 2013 Sep 14.
citation: Weiner GM, Zaichkin J. Updates for the Neonatal Resuscitation Program and Resuscitation Guidelines. Neoreviews. 2022 Apr 1;23(4):e238-e249. doi: 10.1542/neo.23-4-e238.
citation: O'Currain E, O'Shea JE, McGrory L, Owen LS, Kamlin O, Dawson JA, Davis PG, Thio M. Smaller facemasks for positive pressure ventilation in preterm infants: A randomised trial. Resuscitation. 2019 Jan;134:91-98. doi: 10.1016/j.resuscitation.2018.12.005. Epub 2018 Dec 17.