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

Respiratory Distress Syndrome in Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04118400
• Other study ID #: N201907028
• Status: Enrolling by invitation
• Start date: October 31, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2019
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

1. Premature >30week

2. Respiratory distress

Exclusion Criteria:

1. Premature < 30weeks

2. ENT contraindication: fistula

3. Contraindication with orogastric tube or nasogastric

Related Conditions & MeSH terms

• Premature Birth
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• NIV-NAVA
NAVA mode during Non-invasive ventilation
• Nasal CPAP or NIMV mode
Nasal CPAP or NIMV mode during Non-invasive ventilation

Locations

Country	Name	City	State
Taiwan	Hsin-yu LI	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	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 .	Until the date of discharge from ICU, up to 4 weeks
Secondary	Daily patient physiological blood gas status	Defined as daily PaO2/FiO2 from randomization until successful Weaning.	Until the date of discharge from ICU, up to 4 weeks
Secondary	Length of ICU stay	Defined as the duration of ICU admission from randomization to ICU discharge	Until the date of discharge from ICU, up to 4 weeks
Secondary	Length of hospital stay	Defined as the duration of hospital admission from randomization to hospital discharge	Until the date of discharge from ICU, up to 4 weeks
Secondary	Difference in the number of patient ventilator asynchrony	To assess the difference of number of patient ventilator asynchrony	Entire period of ventilatory support, an average of 7 days
Secondary	Ventilation parameters: peak inspiratory pressure in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	Entire period of ventilatory support, an average of 7 days
Secondary	Ventilation parameters : tidal volume in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	through study completion, an average of 7 days
Secondary	Ventilation parameters : PEEP in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	through study completion, an average of 7 days
Secondary	Ventilation parameters : FiO2 in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	through study completion, an average of 7 days
Secondary	Ventilation parameters : Edi peak in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	through study completion, an average of 7 days
Secondary	Ventilation parameters : Edi min in NIV-NAVA	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, Edi peak, Edi min )	through study completion, an average of 7 days
Secondary	Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC Level, RR)	through study completion, an average of 7 days
Secondary	Ventilation parameters : tidal volume in NCPA(or NIMV)	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)	through study completion, an average of 7 days
Secondary	Ventilation parameters : PEEP in NCPA (or NIMV)	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PCl, RR)	through study completion, an average of 7 days
Secondary	Ventilation parameters : FiO2 in NCPA or NIMV	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)	through study completion, an average of 7 days
Secondary	Ventilation parameters : pressure control level in NIMV	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)	through study completion, an average of 7 days
Secondary	Ventilation parameters : RR in NIMV	Evolution of the following parameters: peak inspiratory pressure, tidal volume, PEEP, FiO2, PC, RR)	through study completion, an average of 7 days
Secondary	Clinical parameters of Premature: heart rate in NIV-NAVA	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: respiratory rate in NIV-NAVA	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: SpO2 in NIV-NAVA	Evolution of clinical parameters (SpO2) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: blood pressure in NIV-NAVA	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: heart rate in NCPA(or NIMV)	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: blood pressure in NCPA (or NIMV)	Evolution of clinical parameters (heart rate, respiratory rate, blood pressure) at the beginning and end of each period	through study completion, an average of 7days
Secondary	Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)	Evolution of clinical parameters (SpO2) at the beginning and end of each period	through study completion, an average of 7days