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| Name | Class |
|---|---|
| Dr. von Hauner Children's Hospital | OTHER |
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In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.
This study will be a randomized-controlled clinical study with cross-over design of two treatment phases of 24h duration each (1. Automated FiO2-adjustment (SPO2C), 2. combined use of automated FiO2-adjustment and SpO2-sensitive/apnea-sensitive S-NIPPV (SPO2C + BU), see Figures 1 and 2). The investigators will study two patient groups of premature infants depending on the type of respiratory support at study time: One group, where the infants are on CPAP at study time, and another group of preterm infants who are already supported by nasopharyngeal IPPV at study time. Both studies will be sufficiently powered to show a significant treatment effect if it is present. Study infants will be recruited in the neonatal ICU of the children's hospital, University of Ulm and the neonatal ICU, University of Munich. Both NICU team have participated previously in clinical trials investigated new modes of mechanical ventilation using automated ventilation adjustment in the target population.
Randomization of the sequence of the two study phases will be carried out using sealed envelopes. Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Sophie®-Respirator, Stephan Medizintechnik GmbH, Gackenbach, Germany), which is capable to automatically adjust the FiO2 (called "SPO2C") and to apply noninvasive backup-ventilation (using a noninvasive trigger device (S-NIPPV) or non-synchronized nasal IPPV (NIPPV) based on readings of an incorporated SpO2 monitoring device (Masimo® Radical 7, averaging time 2 sec). Synchronization of NIPPV and detection of apnea is achieved by using the Graseby capsule (Stephan, Vio Healthcare Ltd, Ref. 103560103), which will be secured onto the anterior abdominal wall near to the right costal margin.
Infants on CPAP (first group) will be exposed to the first study phase (SPO2C, or SPO2C + BU, Figure 1) for 24h and then will be switched to the alternate mode for 24h each. Infants, who are already on nasal IPPV (SIPPV or NIPPV) as chosen by the clinical team will be exposed to NIPPV with a standardized inflation rate of 40 breaths/min (nonsynchronized, because this seems to be the current standard of care according to the available literature) and SPO2C, or to SPO2C plus synchronized BU (starting with a rate of 80 inflations/min with stepwise weaning) and then will be switched to the alternate mode for 24h each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Other | Infants on CPAP will receive backup breafs whenever the SpO2 <88 % along with automated FiO2 controller. In the control period they will receive automated FiO2 alone |
|
| NIMV/NIPPV | Other | Infants on NIMV NIPPV will receive an increase in the backup rate to 2 times the rate of the backup triggered by apnoe (apnoe time 5s), whenever the SpO2 under 88% ( max rate 100/min) in the reference period as compared to baseline (automated FiO2 - control + unchanged SIPPV settings) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saturation sensitive backup ventilation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%). | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the number of episodes with an SpO2 <80% | 48 hours | |
| The number of extended/very long episodes outside the SpO2 target range (defined as episodes with a duration of more than 1 minute/3 minutes) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the number of episodes with an SpO2 <80%. | 48hours | |
| the number of episodes with an SpO2 <70%. | 45hours | |
| the mean duration of episodes with an SpO2 with hyperoxemia (SpO2 >96%). |
Inclusion Criteria:
Exclusion Criteria:
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| Mean SpO2. | 48 hours |
| Variability of SpO2 (coefficient of variation) | 48 hours |
| Mean FiO2 during the study time | 48 hours |
| The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hyperoxemia | 48 hours |
| The workload for the medical staff as measured by the number of manual adjustments of FiO2 because of episodes of hypoxemia. | 48 hours |
| Tissue oxygenation measurement (measured with near infrared spectrometry) of different organs (kidney, brain, muscle ) | 48 hours |
| 48hours |
| The mean duration of episodes with an SpO2 <80% | 48 hours |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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