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

Ventilator Weaning Outcome Between Non-invasive Neural Adjusted Ventilator Assist and Nasal Continuous Positive Airway Pressure (or Intermittent Mandatory Ventilation) Modes in Premature Neonates

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome in Premature Infant
• Intervention / Treatment: Procedure: NIV-NAVA; Procedure: Nasal CPAP or NIMV mode

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 802
    • Hsin-yu LI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Premature >30week and have Respiratory distress

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: NIN-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	Procedure: NIV-NAVA; NAVA mode during Non-invasive ventilation
Active Comparator: Nasal CPAP or NIMV; 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	Procedure: Nasal CPAP or NIMV mode; Nasal CPAP or NIMV mode during Non-invasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Principal Investigator: Hsin-yu LI, Taipei Medical University Hospital, Taiwan, R.O.C

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Anticipated): October 6, 2020
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: N201907028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting in January 2022
• IPD Sharing Access Criteria: starting in January 2022
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No