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Clinical Trials/NCT02114567
NCT02114567CompletedNot Applicable

Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.

Southeast University, China1 site in 1 country12 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
trigger work of breathing

Study Overview

Brief Summary

Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level compared with pressure-support ventilation (PSV)

Detailed Description

All patients randomly underwent a 30 mins PSV and NAVA crossover ventilation (15 mins each) at progressive PEEPe levels. Progressive levels of PEEPe were applied stepwise in increments of 40% of baseline static PEEPi, every 30 mins, from zero to 160% of baseline static PEEPi during the protocol (0, 40%, 80%, 120% and 160% of static PEEPi, respectively). During PSV, pressure support level was set to meet a Vt 6ml/kg, I/E cycling was 30% of the maximum inspiratory peak flow, flow trigger was 1L/min, and inspired fraction of oxygen (FiO2) was set to the similar level before the study protocol. During NAVA, NAVA Level was set at 15 cmH2O / µV and a peak airway pressure limit was set in order to apply the same inspiratory pressure support at each PEEPe level during PSV. The new setting of NAVA was defined as NAVA15. Moreover the trigger was set at 0.5 µV and the I/E cycling fixed at 70% of the peak of EAdi. During the entire protocol, FiO2 and peak air way pressure were maintained the same levels at each PEEPe level between PSV and NAVA. Arterial blood gases were measured at the end of PSV or NAVA15 ventilation at each PEEPe level.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •mechanical ventilation AECOPD patients with Static PEEPi measured by End-expiratory airway occlusion method ≥ of 5 cm H2O
  • •Hemodynamics stability (heart rate < 140 beats/min, no vasopressors required, or <5 μg/kg/min dopamine) without any evidence
  • •no sedation or on minimal sedation with low dose of morphine (<3mg/h, by continuous intravenous infusion
  • •Breathing spontaneously
  • •Awake and with positive cooperate

Exclusion Criteria

  • •tracheostomy
  • •treatment abandonment
  • •history of esophageal varices
  • •gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
  • •coagulation disorders (INR ratio>1.5 and Activated partial thromboplastin time > 44 s)
  • •history of acute central or peripheral nervous system disorder or severe neuromuscular disease

Arms & Interventions

PSV ventilation

Experimental

AECOPD Patients who were ventilated wiht PSV, PEEP was titrated and set at 0, 40%, 80% and 120% PEEPi. Pressure support was set to get the tidal volume of 6ml/kg.

Intervention: PEEP titration (Other)

NAVA ventilation

Experimental

AECOPD patients who were ventilated with NAVA, PEEP was titrated and set at 0, 40%, 80% and 120% PEEPi. NAVA level was set to get the tidal volume of 6ml/kg.

Intervention: PEEP titration (Other)

Outcomes

Primary Outcomes

trigger work of breathing

Time Frame: 1 day

Secondary Outcomes

  • patient-ventilator synchrony(1 day)

Investigators

Sponsor
Southeast University, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ling Liu

Dr.

Southeast University, China

Study Sites (1)

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