CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05017727
NCT05017727N/ACompleted

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

King's College Hospital NHS Trust·observational·Posted Aug 24, 2021·Updated Sep 6, 2023

In Brief

An observational study evaluating Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000) for Pre-Term and Respiratory Disease. Completed, enrolled 31 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 24, 2021
Enrollment StartOct 5, 2021
Primary CompletionJan 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.9 years ago

Interventions

Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)device

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.