Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04546568 |
| Other study ID # |
AC20034 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 10, 2020 |
| Est. completion date |
May 3, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or
servo-control systems have been developed that result in tighter control of SpO2 and more
time spent in the intended target range. These systems are already in clinical use. Automated
systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to
keep SpO2 in range. It is possible that this could result in short periods of high or low
oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have
examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on
transcutaneous oxygen tension (TcPO2). There are no studies directly comparing two automated
systems.
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the
use of different automated control systems as a first step in planning future trials. When
this is measured over a small number of hours it is not anticipated that this would have an
influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of two automated
(servo) control devices - IntellO2 (Vapotherm, USA) versus Leoni plus CLAC (Löwenstein
Medical, Germany) - delivering nasal high flow employing automated oxygen titration. Each
infant will act as their own control. Infants born at less than 30 weeks gestation, greater
than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive
Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. 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. A second pulse
oximetry probe will be place for servo control input.
Additional monitoring will be carried out as shown below:
1. TcPO2 monitoring
2. FiO2 monitoring
3. Heart rate monitoring (used to validate SpO2 readings)
4. Arterial gas sampling (only if conducted by the direct care team as part of the routine
care of the infant; no extra blood samples will be taken as part of the study)
FiO2 will be adjusted by the respiratory support devices which have integrated automated
oxygen control, set to maintain a SpO2 target range of 90-95%. The IntellO2 device uses
Precision Flow technology (IntellO2, Vapotherm, USA). By means of a modified closed-loop
algorithm, the devise uses Masimo pulse oximetry to target a user-set SpO2 value. The Leoni
plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical,
Germany) similarly uses MasimoSET (Signal Extraction Technology) to target SpO2 and automate
oxygen control. Both devices have a signal averaging time of 8 seconds (Masimo, Irvine, USA).
The Leoni plus CLAC algorithm is set to a 30 seconds wait time between adjustments, allowing
up to 120 automated adjustments/hour.
SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will
be measured using a Phillips MX500 multiparameter monitor (Phillips, Germany, CE 0366). TcPO2
will be measured using a SenTec Digital Monitoring System with OxiVent sensor (SenTec AG,
Switzerland, European patent No. 1535055, CE 0120). Both monitors are routinely used in
clinical practice. Transcutaneous data will be recorded contemporaneously and the site of the
transcutaneous probe will be rotated on each infant every 2 hours. Control of sensor
temperature and application duration are designed to meet all applicable standards and this
monitoring device is use routinely in many neonatal units.
