Comparison of Automated Oxygen Control With and Without Automated Pressure Control in Preterm Ventilated Infants. (CLIO-VG)
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|ClinicalTrials.gov Identifier: NCT03865069|
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : July 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oxygen Saturation Targetting in Preterm Ventilated Infants||Other: Mode of ventilation (Volume Guarantee)® Other: Mode of ventilation (Volume control Ventilation)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This study will be completed over 2 consecutive 12-hour periods in randomly assigned sequence of automatic oxygen control with Volume Guarantee ventilation (VG) ® and automatic FiO2 control without VG®.Once consent has been obtained, the team will complete the trial registration/randomisation form and access the web based randomisation service at http://www.sealedenvelope.com to obtain unique trial number and assignment of intervention. Before logging onto the website to randomise the following information must be available: Infant's gestation age, Oxygen requirement (Yes/No), Ventilated(Yes/No).|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Automated Oxygen Control (Closed Loop Inspired Oxygen:CLiO2™) With and Without Automated Pressure Control (Volume Guarantee®) in Preterm Ventilated Infants: A Crossover Study (CLIO-VG Study)|
|Actual Study Start Date :||November 1, 2019|
|Actual Primary Completion Date :||July 12, 2020|
|Actual Study Completion Date :||July 12, 2020|
Active Comparator: automated oxygen control with VG®
Automated oxygen control using closed loop inspired oxygen (CLiO2™) with automated pressure control (Volume Guarantee®).
Other: Mode of ventilation (Volume Guarantee)®
This is a volume-targeted mode of ventilation aimed at delivering the set tidal volume of gas by automatically adjusting the peak inspiratory pressure (PIP) on a breath-by-breath basis. Theoretically this should minimise variation in tidal volume delivery as lung compliance and the infant's condition changes. This function is achieved by an automated servo-controlled mechanism. The upper PIP limit can be set by the clinician as a safety mechanism.
Active Comparator: automated oxygen control without VG®
Automated oxygen control using closed loop inspired oxygen (CLiO2™) without automated pressure control (Volume Guarantee®).
Other: Mode of ventilation (Volume control Ventilation)
Volume-Controlled ventilation (VCV) is a type of 'volume targeted' mode. It aims to target be supported the desired tidal volume by delivering a set volume (chosen by the clinician) irrespective of the underlying lung mechanics. The ventilator will generate whatever peak inspiratory pressure is necessary to deliver this volume. There is constant inspiratory flow pattern (a square flow waveform) and peak volume and inspiratory pressure delivery are achieved at the end of inspiration. During the 'control period' of 12 hours without VG, infants will using VCV A/C (assist control) as is our current clinical standard.
- Proportion of time spent with oxygen saturation levels in target range. [ Time Frame: 12 hours for each arm ]The primary outcome of this study is the proportion of time spent with oxygen levels (saturations or SpO2) in the target range (90-95%).
- Proportion of time with very low or very high oxygen levels. [ Time Frame: 12 hours for each arm ]Proportion of time with very low oxygen levels defined as < 80% and very high oxygen levels defined as ≥ 98% when not in room air
- Distribution of oxygen levels during each 12 hour period [ Time Frame: 12 hours for each arm ]Mean (average) concentration of inspired oxygen during each 12-hour period, the hourly inspired oxygen level and proportion of time spent in room air during the 24-hour period.
- Number of manual changes in amount of oxygen [ Time Frame: 12 hours for each arm ]Number of manual changes in amount of oxygen given during both periods(to be documented by the nursing staff in observation chart)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865069
|James Cook University Hospital|
|Middlesbrough, Stockton ON TEES, United Kingdom, TS4 3BW|
|Principal Investigator:||Vrinda Nair, MBBS,FRCPCH||South Tees NHS Trust|