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NCT05017727 Clinical Trial

Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term

Respiratory Disease Clinical Trial

Official title:
Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce Hypoxic Events? A Randomised Controlled Crossover Study in Ventilated Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05017727
Other study ID # 298164
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 5, 2021
Est. completion date January 17, 2023

Study information
Verified date September 2023
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored. Oxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study the investigators aim to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. The achievement of oxygen saturation targets and the number of manual adjustments required will be compared between periods of CLAC and manual control in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. The investigators will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)
The 'Oxygenie' is a closed loop automated oxygen control system that has been incorporated into a software module for the SLE6000 infant ventilators. This software control system allows targeting SpO2 values by controlling FiO2.

Locations
Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (2)
Lead Sponsor Collaborator
King's College Hospital NHS Trust King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (27)

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Outcome
Type Measure Description Time frame Safety issue
Primary The decrease in the percentage of time spent in extremes of hypoxia That will be assessed by evaluating the infant's respiratory status. Over 24 hours
Secondary The increase in the percentage of time spent within target oxygen saturation ranges (94-98%) This will be assessed by evaluating the infant's respiratory status. Over 24 hours
Secondary The reduction in the number of manual adjustments required to the inspired oxygen concentration That will be assessed by reviewing the infant's medical records Over 24 hours
Secondary The reduction in the number of blood gases and chest radiographs That will be assessed by reviewing the infant's medical records Over 24 hours
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