Hypoxia Clinical Trial
— SCO2TOfficial title:
SCO2T Study: A Randomised Crossover Study Comparing Pulse Oximeter Technology Using Automatic Oxygen Control for Preterm Infants
Verified date | May 2024 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 6, 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Days and older |
Eligibility | Inclusion Criteria: 1. Infants born at less than 30 weeks gestation 2. Infants greater than 48 hours of age 3. Infants who are receiving supplementary oxygen 4. Person with parental responsibility able to give consent Exclusion Criteria: 1. Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects) 2. Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support) 3. Parent/person with parental responsibility unable to give informed consent on behalf of the infant 4. Infants born less than 22 weeks gestation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh | Edinburgh | City Of Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Transcutaneous oxygen variability | 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% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor). | 12 hours | |
Secondary | Saturation variability | To discover the variability in SpO2 (measured by standard deviation) 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 | Fraction of inspired oxygen variability | To discover the variability in FiO2 (measured by standard deviation) 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 | Pooled frequency histogram of TcPO2 | To generate a pooled frequency histogram of percentage time at a TcPO2 of below 30mmHg, 30-39.9mmHg, 40-49.9mmHg, 50-59.9mmHg, 60-69.9mmHg, 70-79.9mmHg, and 80mmHg and above for infants 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 | Pooled frequency histogram of SpO2 | To generate a pooled frequency histogram of percentage time at each SpO2 point between 80 - 100% for infants 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 | Pooled frequency histogram of FiO2 | To generate a pooled frequency histogram of the cumulative frequency at a FiO2 of 0.21-0.3, 0.31-0.4, 0.41-0.5, 0.51-0.6, 0.61-0.7, 0.81-0.9 and 0.91-1.0 for infants 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 | Desaturations | To discover the frequency of desaturations for infants 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 | Desaturations | To discover the duration of desaturations for infants 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 | Desaturations | To discover the depth of desaturations and the area (change in PO2 versus time) above and below the set PO2 threshold for infants 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 |
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