Clinical trial NCT04118400: Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
Official title: Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome in Premature Infant
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature \>30week and have Respiratory distress

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.

Eligibility criteria: Inclusion Criteria:

1. Premature \>30week
2. Respiratory distress

Exclusion Criteria:

1. Premature \< 30weeks
2. ENT contraindication: fistula
3. Contraindication with orogastric tube or nasogastric

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Until the date of discharge from ICU, up to 4 weeks
Secondary outcomes:
measure: Daily patient physiological blood gas status
timeFrame: Until the date of discharge from ICU, up to 4 weeks
measure: Length of ICU stay
timeFrame: Until the date of discharge from ICU, up to 4 weeks
measure: Length of hospital stay
timeFrame: Until the date of discharge from ICU, up to 4 weeks
measure: Difference in the number of patient ventilator asynchrony
timeFrame: Entire period of ventilatory support, an average of 7 days
measure: Ventilation parameters: peak inspiratory pressure in NIV-NAVA
timeFrame: Entire period of ventilatory support, an average of 7 days
measure: Ventilation parameters : tidal volume in NIV-NAVA
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : PEEP in NIV-NAVA
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : FiO2 in NIV-NAVA
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : Edi peak in NIV-NAVA
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : Edi min in NIV-NAVA
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : tidal volume in NCPA(or NIMV)
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : PEEP in NCPA (or NIMV)
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : FiO2 in NCPA or NIMV
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : pressure control level in NIMV
timeFrame: through study completion, an average of 7 days
measure: Ventilation parameters : RR in NIMV
timeFrame: through study completion, an average of 7 days
measure: Clinical parameters of Premature: heart rate in NIV-NAVA
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: respiratory rate in NIV-NAVA
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: SpO2 in NIV-NAVA
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: blood pressure in NIV-NAVA
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: heart rate in NCPA(or NIMV)
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: blood pressure in NCPA (or NIMV)
timeFrame: through study completion, an average of 7days
measure: Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)
timeFrame: through study completion, an average of 7days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Hsin-yu LI
Study officials:
affiliation: Taipei Medical University Hospital, Taiwan, R.O.C
name: Hsin-yu LI
role: PRINCIPAL_INVESTIGATOR
References: