NCT01663480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

August 9, 2012

Last Update Submit

July 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • PVBC index

    PVBC2predicts the contribution of the inspiratory muscles versus that of the ventilator during NAVA

    every 3 mins

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Univerity

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • 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(1):43. doi: 10.1186/s13054-015-0775-2.

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Haibo Qiu

    southeast univerity, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 13, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations