Respiratory Distress Syndrome in Premature Infant
Conditions
Brief summary
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm.
Detailed description
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns. The setting and adjustment of the ventilator for premature neonate is not easy, often resulting in poor patient-ventilator interaction, increased work of breathing, patient discomfort and delayed weaning . Recently, a new ventilation mode (NAVA; Neurally Adjusted Ventilatory Assist) mode, allows the respirator to provide a proportional ventilation mode based on the patients' diaphragm electrical activity, which was validated in many domestic and international clinical researches. The NAVA mode improves patient-ventilator interaction, reduces work of breathing and contributes to early weaning and extubation . When participating in this study, the neonate with receive a special oral tube placement, which is used to replace the original gastric tube to monitor the electrical activity of the diaphragm. The aims of the study are: 1. To select the appropriate ventilation mode and parameters (for example, switch to NIV-NAVA mode); 2. To monitor intermittent apnea, bradycardia and the frequency of cyanosis, 3. To pay attention to the changes in maximum peak pressure, adjust appropriate pressure support, and avoid lung injury. The predicted outcomes of NAVA mode for premature neonate may include : 1. Measurement of the lower PIP value to maintain proper and synchronized ventilation; 2. Monitoring of the diaphragm activity (Edi) signal to evaluate the work of breathing and estimate the weaning time.
Interventions
PROCEDURENIV-NAVA
NAVA mode during Non-invasive ventilation
PROCEDURENasal CPAP or NIMV mode
Nasal CPAP or NIMV mode during Non-invasive ventilation
Sponsors
Taipei Medical University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Weeks to 37 Weeks
Healthy volunteers
No
Inclusion criteria
1. Premature \>30week 2. Respiratory distress
Exclusion criteria
1. Premature \< 30weeks 2. ENT contraindication: fistula 3. Contraindication with orogastric tube or nasogastric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | Until the date of discharge from ICU, up to 4 weeks | Defined as the time from the start of mechanical ventilation, defined as either the time of in the ICU and until successful weaning mechanical ventilator, with successful weaning defined as ≥5 days of unassisted spontaneous breathing after . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily patient physiological blood gas status | Until the date of discharge from ICU, up to 4 weeks | Defined as daily PaO2/FiO2 from randomization until successful Weaning. |
| Length of ICU stay | Until the date of discharge from ICU, up to 4 weeks | Defined as the duration of ICU admission from randomization to ICU discharge |
| Length of hospital stay | Until the date of discharge from ICU, up to 4 weeks | Defined as the duration of hospital admission from randomization to hospital discharge |
| Difference in the number of patient ventilator asynchrony | Entire period of ventilatory support, an average of 7 days | To assess the difference of number of patient ventilator asynchrony |
| Ventilation parameters: peak inspiratory pressure in NIV-NAVA | Entire period of ventilatory support, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : tidal volume in NIV-NAVA | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : PEEP in NIV-NAVA | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : FiO2 in NIV-NAVA | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : Edi peak in NIV-NAVA | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : Edi min in NIV-NAVA | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min ) |
| Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV) | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC Level, RR) |
| Ventilation parameters : pressure control level in NIMV | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) |
| Ventilation parameters : PEEP in NCPA (or NIMV) | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PCl, RR) |
| Ventilation parameters : FiO2 in NCPA or NIMV | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) |
| Ventilation parameters : RR in NIMV | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) |
| Clinical parameters of Premature: heart rate in NIV-NAVA | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: respiratory rate in NIV-NAVA | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: SpO2 in NIV-NAVA | through study completion, an average of 7days | Evolution of clinical parameters (SpO2) at the beginning and end of each period |
| Clinical parameters of Premature: blood pressure in NIV-NAVA | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: heart rate in NCPA(or NIMV) | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: respiratory rate in NCPA (or NIMV) | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: blood pressure in NCPA (or NIMV) | through study completion, an average of 7days | Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period |
| Clinical parameters of Premature: SpO2 in NCPAP(or NIMV) | through study completion, an average of 7days | Evolution of clinical parameters (SpO2) at the beginning and end of each period |
| Ventilation parameters : tidal volume in NCPA(or NIMV) | through study completion, an average of 7 days | Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR) |
Countries
Taiwan
Outcome results
None listed