Neonatal pulmonary insufficiency requiring respiratory support and supplemental oxygen Pregnancy and Childbirth
Conditions
Interventions
Intervention
The intervention in this study is an automated FiO2 control system tied to a pulse oximeter. This is embodied as the CLiO2 option of the Avea Ventilator (CareFusion Yorba Linda, CA USA).
Sponsors
Individual Sponsor (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Born with a gestational age between 23 and 32 weeks 2. Weight at study entry between 0.4 to 4 kilograms 3. Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV) 4. Receiving supplemental oxygen at the time of enrollment and for at least 18 hours during the previous 24 hours 5. Expected to complete the 48 hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support 6. Written informed parental consent
Exclusion criteria
Exclusion criteria: 1. Major congenital anomalies 2. Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment. 3. Culture proven sepsis within 72 hours prior to enrollment. 4. If the attending physician deems participation in the study is not in the best interest of the infant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of time with SpO2 within the assigned target range plus time with SpO2 above the assigned target range while FiO2 is set at 0.21. 2. The proportion of time in hypoxemia defined as SpO2 98% while FiO2 > 0.21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Effectiveness End Points: 1. Time Within Assigned Range: To compare the proportion of time within the assigned target range of SpO2 between the periods of manual and automatic FiO2 adjustment. 2. SpO2 Distribution: To compare the distribution of SpO2 between the periods of manual and automatic adjustment of FiO2. This will specifically include the comparisons of the 5th, 25th, 50th, 75th, and 95th percentiles. 3. Fraction of Inspired Oxygen: To compare the fraction of inspired oxygen between the periods of manual and automatic adjustment of FiO2. For this, the mean, standard deviation, median interquartile and hourly-median FiO2 will be calculated over each recording period. 4. Time with FiO2 at 0.21: To compare the proportion of time with FiO2 at 0.21 between the periods of manual and automatic adjustment of FiO2. 5. SpO2 variability: To compare the variability of SpO2 between periods of manual and automatic FiO2 adjustment. This will specifically include the coefficient of variation (Standard deviation divided by the mean) of SpO2 over each recording period. 6. Assessment of Staff Effort: To compare the effort of the clinical staff involved in manually adjusting FiO2 between the periods of manual and automatic FiO2 adjustment. This will specifically include a count of the number of manual changes in FiO2 during each period. 7. Adherence to Guidelines for FiO2 adjustment: To characterize the adherence of the clinical staff to the guidelines for manual FiO2 adjustment during the 24-hour manual period. This will be determined by calculating the proportion of episodes with SpO2 outside the target range in which the clinical staff responded within the time and with a step size of FiO2 adjustment in concordance with these guidelines. Secondary Safety End Points: 1. Extended episodes with SpO2 below or above the target range: To compare the incidence of extended episodes with SpO2 outside the target range between periods of manual and automatic FiO2 adju | — |
Countries
Canada, Germany, Italy, Netherlands, Poland, United Kingdom
Outcome results
None listed