Evidence map›Paper›PMID 35395952›Full record

Trial reportTrials2022

Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled trial in ventilated preterm infants.

Ourania Kaltsogianni, Theodore Dassios, Anne Greenough

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05030337 (Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05030337 narecruitingnot on this map

Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants

TypeinterventionalSponsorKing's College Hospital NHS TrustRan2021 to 2025Enrolled70ConditionsInfant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation ComplicationArmsClosed-loop automated oxygen control (Oxygenie, SLE 6000)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Automated oxygen delivery for preterm infants with respiratory dysfunction.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Ourania KaltsogianniNeonatal Intensive Care Centre, King's College Hospital NHS Foundation Trust, 4th Floor Golden Jubilee Wing, Denmark Hill, London, SE5 9RS, UK.
Theodore DassiosNeonatal Intensive Care Centre, King's College Hospital NHS Foundation Trust, 4th Floor Golden Jubilee Wing, Denmark Hill, London, SE5 9RS, UK. Theodore.dassios@kcl.ac.uk.
Anne GreenoughDepartment of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.ORCID http://orcid.org/0000-0002-8672-5349
King's College Hospital NHS Foundation Trust · GBKing's College London · GB

Funding

Medical Research Council G1000758
6 · The paper itself

Abstract

backgroundMany preterm infants require supplemental oxygen in the newborn period but experience frequent fluctuations of their oxygen saturation levels. Intermittent episodes of hypoxia or hyperoxia increase the risk of complications. Compliance with achievement of oxygen saturation targets is variable, and the need for frequent adjustments of the inspired oxygen concentration increases workload. Closed-loop automated oxygen control systems (CLAC) improve achievement of oxygen saturation targets and reduce both episodes of hypoxia and hyperoxia and the number of manual adjustments. This study investigates whether CLAC compared with manual oxygen control reduces the duration of mechanical ventilation in preterm infants born at less than 31 weeks of gestation.

methodsThis randomised controlled trial performed at a single tertiary neonatal unit is recruiting 70 infants born at less than 31 weeks of gestational age and within 48 h of initiation of mechanical ventilation. Infants are randomised to CLAC or manual oxygen control from recruitment until successful extubation. The primary outcome is the duration of mechanical ventilation, and secondary outcomes are the percentage of time spent within target oxygen saturation ranges, the time spent in hypoxia or hyperoxia, the number of manual adjustments required, the number of days on oxygen, the incidence of bronchopulmonary dysplasia and the length and cost of neonatal unit stay. The study is performed following informed parental consent and was approved by the Yorkshire and the Humber-Sheffield Research Ethics Committee (protocol version 1.1, 13 July 2021). DISCUSSION: This trial will investigate the effect of CLAC on the duration of mechanical ventilation, which is an important clinical outcome as prolonged mechanical ventilation is associated with important adverse outcomes, such as bronchopulmonary dysplasia.

trial registrationClinicalTrials.Gov NCT05030337 . Registered on 17 August 2021.

Indexed as

Bronchopulmonary DysplasiaHyperoxiaHumansHypoxiaInfantInfant, NewbornInfant, PrematureOxygenRespiration, ArtificialOxygenClosed loop automated oxygen controlIntermittent hypoxemia and hyperoxemiaMechanical ventilationPreterm infants

Identifiers

PMID35395952
PMCPMC8994422
OpenAlexW4223544540

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.