Evidence map›Paper›PMID 41126304›Full record

ArticleTrials2025

Effect of different targeted tidal volumes during high-frequency oscillation with volume-targeted ventilation on cerebral blood flow velocity and cardiac output: study protocol for a randomised crossover study.

Ourania Kaltsogianni, Mahesh Nanjundappa, Grace Okoye, Anne Greenough, Theodore Dassios

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06719284 (Crossover Study of the Cerebral Blood Flow and Cardiac Output At Different Targeted Tidal Volumes During High Frequency Oscillation with Volume Targeted Ventilation), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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NCT06719284 narecruitingnot on this map

Crossover Study of the Cerebral Blood Flow and Cardiac Output At Different Targeted Tidal Volumes During High Frequency Oscillation with Volume Targeted Ventilation (HFO&VTV)

TypeinterventionalSponsorKing's College Hospital NHS TrustRan2025 to 2026Enrolled27ConditionsHigh Frequency Oscillation, Volume Targeted VentilationArmsHFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order, HFOV at the settings applied prior to the study
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Ourania KaltsogianniDepartment of Women and Children's Health, School of Life Course and Population Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Mahesh NanjundappaNeonatal Intensive Care Centre, King's College Hospital NHS Foundation Trust, London, UK.
Grace OkoyeNeonatal Intensive Care Centre, King's College Hospital NHS Foundation Trust, London, UK.
Anne GreenoughDepartment of Women and Children's Health, School of Life Course and Population Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Theodore DassiosDepartment of Women and Children's Health, School of Life Course and Population Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. theodore.dassios@kcl.ac.uk.ORCID http://orcid.org/0000-0001-5258-5301

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh frequency oscillation (HFO) is a lung protective ventilation strategy for newborn infants due to the small tidal volume delivery at fast frequencies, but has been associated with an increased risk of brain injury. High-frequency oscillation with volume-targeted ventilation (HFO&VTV) is a new mode of HFO that applies a targeted tidal volume (VThf) set by the clinician and achieves less fluctuations of carbon dioxide levels and therefore reduces the risk of brain injury. The optimal starting VThf values, however, have not been explored to date. This study investigates the optimum starting settings in newborn infants receiving HFO by comparing the cerebral blood flow velocity and cardiac output at different tidal volume targets of HFO&VTV.

methodsThis randomised crossover trial performed at a single tertiary neonatal unit will be recruiting 25 infants of any gestation and at any postnatal age receiving HFO. Each infant will receive three targeted tidal volumes on HFO&VTV in random order with control periods in between. The resistive index (RI) as an indicator of cerebral blood flow in term-born infants and the cardiac output for all infants in the study will be assessed in each period. The primary outcome will be the reduction in the RI that will be measured on term-born infants using the anterior cerebral artery Doppler. The secondary outcome will be the improvement in cardiac output that will be assessed in all infants with bedside ECHO. The study will be performed following informed parental consent and was approved by the London-Hampstead research ethics committee (Protocol version 2, 22/01/25). DISCUSSION: This trial will investigate the effect of HFO&VTV on cerebral blood flow velocity and cardiac output to further elucidate the optimal volume targeting range in newborn infants.

trial registrationClinicalTrials.Gov, NCT06719284 , registered on 04/12/2024.

Indexed as

Cardiac OutputCerebrovascular CirculationHigh-Frequency VentilationTidal VolumeBlood Flow VelocityCross-Over StudiesFemaleHumansInfant, NewbornRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUltrasonography, Doppler, TranscranialCardiac outputCerebral blood flowHigh-frequency oscillationNewborn infantsVolume targeting

Identifiers

PMID41126304
PMCPMC12542444

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