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To Identify the Proportionality of Respiratory Work Under Different NAVA Level

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01663480
Enrollment
12
Registered
2012-08-13
Start date
2011-03-31
Completion date
2013-12-31
Last updated
2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Brief 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.

Interventions

None listed

Sponsors

Ling Liu
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PVBC indexevery 3 minsPVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026