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To Identify the Proportionality of Respiratory Work Under Different NAVA Level

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ClinicalTrials.gov Identifier: NCT01663480
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

August 9, 2012
August 13, 2012
July 29, 2014
March 2011
December 2013   (Final data collection date for primary outcome measure)
PVBC index [ Time Frame: every 3 mins ]
PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA
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Complete list of historical versions of study NCT01663480 on ClinicalTrials.gov Archive Site
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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

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.

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Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
patient with respiratery failure need mechinical ventilation, and will be tolerance short time loe level support ventilation
Respiratory Failure
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Liu L, Liu S, Xie J, Yang Y, Slutsky AS, Beck J, Sinderby C, Qiu H. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist in patients with acute respiratory failure. Crit Care. 2015 Feb 18;19:43. doi: 10.1186/s13054-015-0775-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Ling Liu, Southeast University, China
Ling Liu
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Study Director: Haibo Qiu southeast univerity, China
Southeast University, China
July 2014