Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates

• Conditions: Respiratory Distress Syndrome in Premature Infant
• Interventions: Procedure: NIV-NAVA; Procedure: Nasal CPAP or NIMV mode

• Registration Number: NCT04118400
• Lead Sponsor: Taipei Medical University Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Study Start: 2019-10-31
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12
• Primary Completion: 2020-10-06
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Premature >30week
2. Respiratory distress

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: NIN-NAVA	NIV-NAVA	* Premature\>30weeks with respiratory distress * PI to determine eligibility or exclusion * Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization * PI will not be blinded to the intervention (not feasible) * Place the catheter to optimize position * ABG or VBG to be obtained at 2 hrs. post NIV-NAVA * NIV-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol
Active Comparator: Nasal CPAP or NIMV	Nasal CPAP or NIMV mode	* Premature\>30weeks with respiratory distress * PI to determine eligibility or exclusion * Randomize to either NIV-NAVA or Nasal CPAP (NIMV) 1:1 randomization * PI will not be blinded to the intervention (not feasible) * Place the catheter to optimize position * ABG or VBG to be obtained at 2 hrs. post Nasal CPAP or NIMV * NCPAP or NIMV settings will be weaned or increased as the clinical situation demands and outlined in the protocol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 : 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)
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 : 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 : 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

Trial Locations

Locations (1)

Hsin-yu LI; 🇨🇳 Taipei, Taiwan