To Identify the Proportionality of Respiratory Work Under Different NAVA Level

Respiratory Failure Clinical Trial

Official title:

Assessment of Patient-ventilator Breath Contribution (PVBC) During Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663480
• Other study ID #: NAVA3
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: July 28, 2014
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The primary purpose of mechanical ventilation is to sufficiently unload the respiratory muscles and maintain adequate ventilation in spontaneously breathing patients. When the mechanical ventilatory assist is synchronized to the patient's inspiratory effort, both the patient and the mechanical ventilator will contribute to the lung-distending pressure, necessary to overcome inspiratory load and generate the tidal volume (Vt). Unfortunately, conventional modes of mechanical ventilation cannot quantify the impact of the ventilatory assist performed by the ventilator and the patient. Inadequate levels of assist are associated with adverse effects such as development of fatigue or patient-ventilator dissynchrony and diaphragm impairment, and over assist also lead to diaphragm atrophy and weaning delay.

The newly introduced neurally adjusted ventilatory assist (NAVA) has made it possible to measure the neural activity of the respiratory centers (expressed by the diaphragm electrical activity, EAdi). EAdi is a validated variable to quantify the neural respiratory drive, little is known about its usefulness to evaluate the contribution of the patient's inspiratory muscle effort relative to that of the mechanical ventilator, which would be of crucial importance to appropriately titrate the level of assist.

During NAVA, the patient's efficiency to transform neural effort (EAdi) into Vt, expressed as neuroventilatory efficiency (NVE), may be a useful predictor for determining the contribution of the patient and the ventilator to generate a breath.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:(1) Intubated or tracheostomied patients with ARF due to COPD (10 patients) or other reasons (10 patients) who were undergoing assisted mechanical ventilation, (2) be able to tolerate short time (30 minutes) spontaneous breathing (PEEP=5cmH2O, without assist), (3) awake and do not need high dose of sedation

Exclusion Criteria:(1) age <18 or >80 years, (2) ready for extubation, (3) history of esophageal varices, (4) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (5) coagulation disorders (INR ratio>1.5 and APTT>44 s), (6) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (7) history of leukemia, severe chronic liver or chronic cardiac disease, (8) solid organ transplantation, (9) malignant tumor.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
China	Southeast Univerity	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Ling Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PVBC index	PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA	every 3 mins	No