To Identify the Proportionality of Respiratory Work Under Different NAVA Level

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Southeast University, China
Sponsor:
Information provided by (Responsible Party):
Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01663480
First received: August 9, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patient with respiratery failure need mechinical ventilation, and will be tolerance short time loe level support ventilation

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663480

Locations
China, Jinagsu
Southeast Univerity Recruiting
Nanjing, Jinagsu, China, 210009
Contact: Ling Liu       liuling6600@yahoo.com.cn   
Principal Investigator: Haibo Qiu         
Sponsors and Collaborators
Ling Liu
Investigators
Study Director: Haibo Qiu southeast univerity, China
  More Information

No publications provided

Responsible Party: Ling Liu, professor, Southeast University, China
ClinicalTrials.gov Identifier: NCT01663480     History of Changes
Other Study ID Numbers: NAVA3
Study First Received: August 9, 2012
Last Updated: August 9, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014