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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Two-handed facemask hold | Experimental | Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver positive inspiratory pressure (PIP) via the T-piece. The operators may be any member of the neonatal team, who have undergone Neonatal Resusctiation Programme (NRP) certification. Standardised mask size and shape for gestation and weight, as per local policy, will be used. |
|
| Control: One-handed facemask hold | Placebo Comparator | One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering positive pressure ventilation (PPV) via the T-piece. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-handed facemask hold | Procedure | Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mask leak | 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. | Over a maximum of 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest oxygen saturation | 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. | Over a maximum of 20 minutes |
| Highest supplemental FiO2 used during facemask ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Maternity Hospital Dublin | Dublin | Leinster | D02 YH21 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Newborn Life Support. J. Fawke et al. Resuscitation Council UK. May 2021. | ||
| 36746525 | Result | 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. | |
| 21071683 |
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Data will be pseudononymised and will be presented/shared only as collated values, as opposed to individual results.
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Parallel group randomised controlled trial
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This is an unblinded study as it is not possible to blind the provider to the type of mask hold. However, the operators will be blinded to the respiratory function monitor measurements feedback. This will be achieved by obscuring the colour sensor with brown, opaque tape and covering the Monivent screen. The outcome assessor will be blinded to the group allocation.
| Control: One-handed facemask hold | Procedure | One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering PPV via the T-piece. |
|
Highest percentage FiO2 used during the period of facemask ventilation, as indicated by the set dial on the Neopuff. |
| Over a maximum of 20 minutes |
| Positive inspiratory pressure during facemask ventilation | Positive inspiratory pressure used during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor. | Over a maximum of 20 minutes |
| Percentage of obstructed breaths during facemask ventilation | Percentage of obstructed breaths during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor. | Over a maximum of 20 minutes |
| Tidal volume during facemask ventilation | Measured tidal volume during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor. | Over a maximum of 20 minutes |
| Number of times facemask position is adjusted during facemask ventilation | Number of times clinical team needs to adjust mask position during the period of facemask ventilation. | Over a maximum of 20 minutes |
| Duration of facemask ventilation | Time duration of facemask ventilation | Over a maximum of 20 minutes |
| Crossover to other handhold | 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. | Over a maximum of 20 minutes |
| User opinion of mask hold | Survey of operator opinions about mask hold used, and their usual preference. | Over a maximum of 20 minutes |
| Lowest heart rate | 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. | Over a maximum of 20 minutes |
| Result |
| 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. |
| 38389164 | Result | 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. |
| 24041823 | Result | 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. |
| 35362042 | Result | 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. |
| 30572069 | Result | 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. |