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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
Sponsor:
Information provided by (Responsible Party):
South Tees Hospitals NHS Foundation Trust

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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%).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)



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Ages Eligible for Study:   23 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Preterm infants less than 37 weeks (23+0 to 36+6 weeks)

  • Who are receiving conventional mechanical ventilation through an endotracheal tube.
  • On supplemental oxygen at the time of enrolment (Defined as requiring more than 0.21 FiO2 to maintain saturation in the target range).

Exclusion Criteria:

  • Infants more than or equal to 37weeks
  • Preterm infants with congenital anomalies
  • Infants on a non-conventional mode of ventilation Infants on inhaled Nitric Oxide

Information from the National Library of Medicine

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


Locations
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United Kingdom
James Cook University Hospital
Middlesbrough, Stockton ON TEES, United Kingdom, TS4 3BW
Sponsors and Collaborators
South Tees Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Vrinda Nair, MBBS,FRCPCH South Tees NHS Trust
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: South Tees Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03865069    
Other Study ID Numbers: 2018077
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Tees Hospitals NHS Foundation Trust:
automated oxygen control
automated pressure control
CLIO
Volume guarantee
preterm
ventilated infants
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications