Health Condition 1: J962- Acute and chronic respiratory failure
Conditions
Interventions
Intervention1: Rule based non-fuzzy algorithm (PRICO ): The automated oxygen control follows an non-fuzzy-logic algorithm. PRICO integrated into the Fabian ventilator allows for continuous monitor
Sponsors
Sumit Bhadu
Eligibility
Inclusion criteria
Inclusion criteria: 1 Neonates who are less than or equals to 44 weeks post-menstrual age irrespective of day of life and day of hospital stay 2 Receiving respiratory support through mechanical ventilator irrespective of the mode of ventilation (both non-invasive and invasive modes of ventilation) 3 Requiring supplemental oxygen greater than or equal to 25%
Exclusion criteria
Exclusion criteria: 1 Major or life-threatening congenital anomalies 2 Hemodynamic instability requiring vasopressors or inotropes or inhaled nitric oxide 3 Culture proven sepsis or Meningitis within 72 hours prior to enrollment 4 Refusal of consent by the parents 5 Refusal to include by the treating team due to perceived clinical instability of the neonate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time (in %) where the SpO2 remained within the target rangeTimepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of time spent above the target range while FiO2 was set at 21%Timepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B;Proportion of time spent below & above SpO2 target rangesTimepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B;Frequency of prolonged episodes of SpO2 outside the target range, below the critical SpO2 of 80%, above the critical SpO2 of 98% & below the extremely low SpO2 of 70%. Prolonged is defined as more than 30 seconds for this studyTimepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B ;Number of episodes where the SpO2 overshot the target range following automated adjustment after a SpO2 of below 80%. This overshooting will be considered as significant only if lasted for more than 30 seconds in the 2 minutes period following desaturationTimepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B;Time (in seconds) to reach the target range when SpO2 was below the target range limit, when was above the target range limit, when was below the critical limit of 80%, when was below the extremely critical limit of 70% & when was above the critical limit of 98%Timepoint: In a 24 hours period from randomization for intervention A followed by another 24 hours period for intervention B | — |
Countries
India
Contacts
Public ContactVenkataseshan Sundaram
PGIMER Chandigarh
Outcome results
None listed