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Clinical Trials/NCT01042080
NCT01042080
Completed
Not Applicable

Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

Hôpital Européen Marseille2 sites in 1 country16 target enrollmentDecember 2009
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ConditionsChronic Obstructive Pulmonary Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Hôpital Européen Marseille
Enrollment
16
Locations
2
Primary Endpoint
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
September 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Hôpital Européen Marseille
Responsible Party
Principal Investigator
Principal Investigator

Jerome Allardet-Servent, MD

MD, MSc

Hôpital Européen Marseille

Eligibility Criteria

Inclusion Criteria

  • •History of chronic obstructive pulmonary disease
  • •Admitted for acute respiratory failure requiring invasive mechanical ventilation
  • •Currently receiving pressure support ventilation

Exclusion Criteria

  • •Age \< 18 years
  • •Respiratory rate \> 35 bpm
  • •Severe hypoxemia with SpO2 \< 88 % and FIO2 \> 50 %
  • •Heart rate \> 120 bpm
  • •Systolic arterial pressure \< 90 mmHg
  • •Contraindication to naso-gastric tube's insertion

Outcomes

Primary Outcomes

Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)

Time Frame: 5 minutes

Secondary Outcomes

  • Arterial blood gases(20 minutes)
  • Trigger delay(5 minutes)
  • Ineffective inspiratory effort(5 minutes)
  • Dynamic intrinsic PEEP(5 minutes)

Study Sites (2)

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