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NCT03865069: CLIO-VG

Comparison of Automated Oxygen Control With and Without Automated Pressure Control in Preterm Ventilated Infants.

Completed NA Last updated 20 July 2020
What this trial tests

NA trial testing Mode of ventilation (Volume Guarantee)® in Oxygen Saturation Targetting in Preterm Ventilated Infants in 19 participants. Completed in 12 July 2020.

Timeline
1 November 2019
Primary endpoint
12 July 2020
12 July 2020

Quick facts

Lead sponsorSouth Tees Hospitals NHS Foundation Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment19
Start date1 November 2019
Primary completion12 July 2020
Estimated completion12 July 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

South Tees Hospitals NHS Foundation Trust

Who can join

Adults 23 Weeks to 36 Weeks, any sex, with Oxygen Saturation Targetting in Preterm Ventilated Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a cross-over randomized study. Eligible participants are preterm infants born at less than 37 weeks gestation (23+0 to 36+6 weeks), who are receiving conventional mechanical ventilation through an endotracheal tube and have a need for supplemental oxygen at the time of enrolment. The planned sample size is 19 subjects completing the study with both arms (38 study periods). The objective of this crossover study is to evaluate the efficacy of the automatic oxygen control function with or without Volume Guarantee®(automatic control of ventilator pressure to deliver the set volume) mode of ventilation in keeping oxygen levels in the safe target range (90 to 95%) in ventilated preterm infants requiring oxygen therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study).
    Nair V, Lal MK, Gillone J, Kannan Loganathan P, et al · · 2022 · cited 1× · PMID 34233907 · DOI 10.1136/archdischild-2021-321712

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