Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support

Summary

Babies admitted in the NICU (neonatal intensive care unit) frequently need supplemental oxygen to keep their oxygen saturation (SpO2) in target range (TR). Hypoxia and hyperoxia episodes should be avoided while working toward this goal. Preterm babies are particularly vulnerable to abnormal oxygen levels, and adverse effects of hyperoxia and oxygen toxicity may result in retinopathy of prematurity and bronchopulmonary dysplasia. Similarly, mortality may rise due to hypoxic events. In routine practice, the SpO2 target is usually achieved by manual adjustment of FiO2 (fraction of inspired oxygen), but it usually does not accomplish the desired SpO2 target, leading to episodes of hyperoxia and hypoxia and increased risk of complications. A study was conducted in multiple centers involving extremely preterm babies, the results of which depicted that the babies on manual control of FiO2 spent only 48% of their time with SpO2 in the target range, 16% below the target range, and 36% above it. The compliance of the SpO2 target range was also variable in these centers. There is a need to improve compliance by using automated oxygen control systems.

At the Aga Khan University Hospital (AKUH) investigators have included SLE 6000 (SLE, Croydon, UK) ventilators in their NICU (neonatal intensive care unit) which have automated oxygen control device "Oxygenie" that continuously adjusts FiO2 (fraction of inspired oxygen) of the patient to keep SpO2 in the target range, avoiding abnormal oxygen levels. This also reduces the workload on staff and improves patient care. Investigators usually put preterm babies on these ventilators so that SpO2 can be kept most of the time in the target range. When the OxyGenie and SpO2 monitoring are added to the SLE 6000 ventilator, it becomes possible to accurately regulate and deliver closed loop oxygen to preterm infants. This automated oxygen control system limits episodes of both hypoxia and hyperoxia by using the VDL 1.1 algorithm that uses an adaptive Proportional-Integral-Derivative (PID) algorithm to control the FiO2 adjustments in response to changes in SpO2. This keeps SpO2 within a target range (TR) which user selects. A randomized crossover trial comparing two devices for automated oxygen control in preterm infants included the SLE 6000 ventilator as one of its devices.

Conditions

• Preterm

Interventions

DEVICE

automated oxygen vs manual oxygen

Patient characteristics, ventilator, and blood gas parameters at the time of study will be shown in Tabular form. At the start of the study, half of the babies will be randomly assigned to a manual 12-hour period where a bedside nurse will adjust the FiO2 of the baby according to SpO2 levels, and half of the babies to an automated 12-hour period where Oxygenie will adjust FiO2 according to target SpO2 levels. After 12 hours, they will be shifted to contralateral intervention. The ventilator parameters (peak inspiratory pressure, positive end expiratory pressure, and rate) will be compared between the automated and manual 12-hour periods. The amount of time spent within different ranges of SpO2 will also be measured and shown in tabular form.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan

  lead OTHER

Principal Investigators

• Ali Shabbir Hussain · Aga Khan University Hospital, Karachi, Pakistan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

13 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-03

Primary Completion

2025-03-01

Completion

2025-08-13

Countries

• Pakistan

Study Locations