Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor

Summary

Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.

Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.

Research suggests that different automated devices control oxygen effectively as measured by the readings from their internal oxygen saturation monitoring systems. When compared to free-standing saturation monitors there appears to be variations in measured oxygen levels between devices. This could have important clinical implications.

This study aims to show the different achieved oxygen levels when babies are targeted to a set target range. Babies in the study will have both a saturation monitor and a transcutaneous oxygen monitor at the same time. Both types of monitor have been in long term use in neonatal units.

For a period of 12 hours, each baby will have their oxygen adjusted automatically using two different internal oxygen monitoring technologies (6 hours respectively). The investigators will compare the range of oxygen levels that are seen between the two oxygen saturation monitoring technologies.

The investigators will study babies born at less than 30 weeks gestation, who are at least 2 days old, on nasal high flow and still require added oxygen.

Conditions

• Premature
• Premature Infant
• Oxygen Therapy
• Hypoxia
• Hyperoxia
• Obstetric Labor, Premature

Interventions

DEVICE

Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM

FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value. Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• University of Edinburgh

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

2 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-27

Primary Completion

2023-08-28

Completion

2023-08-28

Countries

• United Kingdom

Study Locations