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  • Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study)

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Original research
Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study)
  1. Vrinda Nair1,2,
  2. Mithilesh Kumar Lal1,
  3. Jenna Gillone1,
  4. Prakash Kannan Loganathan1,
  5. Thomas Edward Bachman3,4
  1. 1 Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK
  2. 2 Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
  3. 3 Medtrx.org, Lake Arrowhead, California, USA
  4. 4 Biomedical Technology, Czech Technical University, Prague, Czech Republic
  1. Correspondence to Dr Vrinda Nair, Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough TS4 3BW, UK; vrinda.nair1{at}nhs.net

Abstract

Objective The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%–95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2).

Design A single-centre randomised crossover study.

Settings A level III neonatal intensive care unit.

Patients Preterm infants receiving mechanical ventilation and oxygen requirement >21%.

Interventions Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2).

Outcomes The primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%–95%) .

Results Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24–28) and birth weight 685 g (IQR: 595–980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57–81) in VG vs 75% (58–83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups.

Conclusion There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study.

Trial registration number NCT03865069.

  • neonatology
  • technology

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article.

https://doi.org/10.1136/archdischild-2021-321712

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article.

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    Footnotes

    • Contributors VN and MKL contributed equally to the paper. VN and MKL were responsible for concept, design, data collection, interpretation of data, data analysis and drafting initial manuscript and approved the final manuscript. JG was responsible for concept, design and drafting initial manuscript and approved the final manuscript. PKL was responsible for design, data collection, interpretation of data and drafting initial manuscript and approved the final manuscript. TEB was responsible for design, interpretation of data, data analysis and drafting initial manuscript and approved the final manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

    • Funding BD/CareFusion provided the funding for the study.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.