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

NCT ID: NCT04118400

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-08-31

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

NIV-NAVA

Intervention Type: PROCEDURE

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

Nasal CPAP or NIMV mode

Intervention Type: PROCEDURE

Nasal CPAP or NIMV mode during Non-invasive ventilation

Interventions

NIV-NAVA

NAVA mode during Non-invasive ventilation

Intervention Type: PROCEDURE

Nasal CPAP or NIMV mode

Nasal CPAP or NIMV mode during Non-invasive ventilation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsin-yu LI

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital, Taiwan, R.O.C

Locations

Hsin-yu LI

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N201907028

Identifier Type: -

Identifier Source: org_study_id