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Is it Necessary to Set External PEEP in AECOPD Patients

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ClinicalTrials.gov Identifier: NCT02114567
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

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)

Condition or disease Intervention/treatment Phase
Acute Exacerbation Chronic Obstructive Pulmonary Disease Other: PEEP titration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: PSV ventilation
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.
Other: PEEP titration
In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi

Experimental: NAVA ventilation
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.
Other: PEEP titration
In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi

Primary Outcome Measures :
  1. trigger work of breathing [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. patient-ventilator synchrony [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. tracheostomy
  2. treatment abandonment
  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 Activated partial thromboplastin time > 44 s)
  6. history of acute central or peripheral nervous system disorder or severe neuromuscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114567

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China, Jiangsu
Nanjing Zhong-Da Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
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Study Director: ling liu, md Department of Critical Care Medicine, Nanjing Zhongda Hospital and School of Medicine, Southeast University, China
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ling Liu, Dr., Southeast University, China
ClinicalTrials.gov Identifier: NCT02114567    
Other Study ID Numbers: COPDNAVA
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Ling Liu, Southeast University, China:
work of breathing
patient-ventilator synchrony
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases