SCO2T (Servo vs. Servo)

NCT04546568 | Terminated

• 1 other identifier: AC20034
• Study Type: interventional
• Target: 11
• 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. Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices. The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow. For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.

Conditions

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

Keywords

Servo Control; Close-Loop Automated Oxygen Control

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperoxia and hypoxia on transcutaneous monitoring

  To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% using two automated (servo) control devices (Leoni plus CLAC and Vapotherm IntellO2) delivering nasal high flow.

  12 hours

Secondary Outcomes (8)

• Transcutanous oxygen variability

  12 hours

• Incidence of hyperoxia and hypoxia on saturation monitoring

  12 hours

• Saturation variability

  12 hours

• Fraction of inspired oxygen variability

  12 hours

• Pooled frequency histogram of TcPO2

  12 hours

Study Arms (2)

Servo control - Leoni plus CLAC

EXPERIMENTAL

Automated control of oxygen. The oxygen saturation target range will be set to 90-95% as per standard 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)) - Leoni plus CLAC

Servo control - IntellO2 Precision Flow, 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 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)) - Leoni plus CLAC DEVICE

FiO2 adjustments will be made by the Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.

Servo control - Leoni plus CLAC

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). Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.

Servo control - IntellO2 Precision Flow, 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)

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: This study is randomised but not blinded. Infants will be randomised to commence on either automated (servo) control using either Leoni plus CLAC or IntellO2, Vapotherm. SpO2 (range 90-95%) will be continuously monitored 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 (servo) control using Leoni plus CLAC (Leoni plus, Löwenstein Medical, Germany) to target SpO2 to 90-95%, and half will have instructions to commence on automated (servo) control using IntellO2 Precision Flow (IntellO2, Vapotherm, USA).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised cross-over study of servo-controlled oxygen targeting in premature infants, with infants acting as their own controls

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: August 10, 2020
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: June 2, 2023

Record last verified: 2022-05

Locations

GB (1)