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Clinical Trials/NCT04118400
NCT04118400
Unknown
N/A

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

Taipei Medical University Hospital1 site in 1 country60 target enrollmentOctober 31, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Distress Syndrome in Premature Infant
Sponsor
Taipei Medical University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Duration of mechanical ventilation
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2019
End Date
August 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Premature \>30week
  • Respiratory distress

Exclusion Criteria

  • Premature \< 30weeks
  • ENT contraindication: fistula
  • Contraindication with orogastric tube or nasogastric

Outcomes

Primary Outcomes

Duration of mechanical ventilation

Time Frame: 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 Outcomes

  • Length of ICU stay(Until the date of discharge from ICU, up to 4 weeks)
  • Length of hospital stay(Until the date of discharge from ICU, up to 4 weeks)
  • Daily patient physiological blood gas status(Until the date of discharge from ICU, up to 4 weeks)
  • Difference in the number of patient ventilator asynchrony(Entire period of ventilatory support, an average of 7 days)
  • Ventilation parameters: peak inspiratory pressure in NIV-NAVA(Entire period of ventilatory support, an average of 7 days)
  • Ventilation parameters : tidal volume in NIV-NAVA(through study completion, an average of 7 days)
  • Ventilation parameters : PEEP in NIV-NAVA(through study completion, an average of 7 days)
  • Ventilation parameters : FiO2 in NIV-NAVA(through study completion, an average of 7 days)
  • Ventilation parameters : Edi peak in NIV-NAVA(through study completion, an average of 7 days)
  • Ventilation parameters : Edi min in NIV-NAVA(through study completion, an average of 7 days)
  • Ventilation parameters : peak inspiratory pressure in NCPA (or NIMV)(through study completion, an average of 7 days)
  • Ventilation parameters : tidal volume in NCPA(or NIMV)(through study completion, an average of 7 days)
  • Ventilation parameters : PEEP in NCPA (or NIMV)(through study completion, an average of 7 days)
  • Ventilation parameters : FiO2 in NCPA or NIMV(through study completion, an average of 7 days)
  • Ventilation parameters : pressure control level in NIMV(through study completion, an average of 7 days)
  • Ventilation parameters : RR in NIMV(through study completion, an average of 7 days)
  • Clinical parameters of Premature: heart rate in NIV-NAVA(through study completion, an average of 7days)
  • Clinical parameters of Premature: respiratory rate in NIV-NAVA(through study completion, an average of 7days)
  • Clinical parameters of Premature: SpO2 in NIV-NAVA(through study completion, an average of 7days)
  • Clinical parameters of Premature: blood pressure in NIV-NAVA(through study completion, an average of 7days)
  • Clinical parameters of Premature: heart rate in NCPA(or NIMV)(through study completion, an average of 7days)
  • Clinical parameters of Premature: respiratory rate in NCPA (or NIMV)(through study completion, an average of 7days)
  • Clinical parameters of Premature: blood pressure in NCPA (or NIMV)(through study completion, an average of 7days)
  • Clinical parameters of Premature: SpO2 in NCPAP(or NIMV)(through study completion, an average of 7days)

Study Sites (1)

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