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

NCT04866342 | Completed

• 1 other identifier: AC20114
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Servo Control; Closed-Loop Automated Oxygen Control; Pulse oximeter technology

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperoxia and hypoxia on saturation monitoring

  To discover the percentage time spent within target SpO2 range of 90-95% when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).

  12 hours

Secondary Outcomes (9)

• Transcutaneous oxygen variability

  12 hours

• Saturation variability

  12 hours

• Fraction of inspired oxygen variability

  12 hours

• Pooled frequency histogram of TcPO2

  12 hours

• Pooled frequency histogram of SpO2

  12 hours

Study Arms (2)

Servo control - Masimo oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm)

EXPERIMENTAL

Automated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets.

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

Servo control - Nellcor oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm)

ACTIVE COMPARATOR

Automated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets.

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

Interventions

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

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.

Servo control - Masimo oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm); Servo control - Nellcor oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm)

Eligibility Criteria

• Age: 2 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants born at less than 30 weeks gestation
• Infants greater than 48 hours of age
• Infants who are receiving supplementary oxygen
• Person with parental responsibility able to give consent

You may not qualify if:

• Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
• Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
• Parent/person with parental responsibility unable to give informed consent on behalf of the infant
• Infants born less than 22 weeks gestation

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh

Edinburgh, City Of Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth; Hypoxia; Hyperoxia; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: commence on either Masimo oximetry or Nellcor oximetry using the Oxygen Assist Module (OAM), IntellO2 Vapotherm device. SpO2 (range 90-95%) will be continuously monitored on a second pulse oximetry probe connected to a bedside multiparameter monitor as per normal standard of care. To remove selection bias the 20 infants will be randomised using sealed, windowless, envelopes. Half will instruct to commence on automated control (Precision Flow technology IntellO2, Vapotherm, USA) using Masimo oximetry technology to target SpO2 to 90-95%. Half will have instructions to commence on automated control (Precision Flow technology IntellO2, Vapotherm, USA) using Nellcor oximetry technology to target SpO2 to 90-95%.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, single centre, randomised crossover trial of two different internal oximeter monitoring systems in an automated (servo) control device - IntellO2 (Vapotherm, USA) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: April 29, 2021
• Study Start: November 27, 2020
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-05

Locations

GB (1)