Is it Necessary to Set External PEEP in AECOPD Patients
Primary Purpose
Acute Exacerbation Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEEP titration
Sponsored by
About this trial
This is an interventional basic science trial for Acute Exacerbation Chronic Obstructive Pulmonary Disease focused on measuring AECOPD, work of breathing, patient-ventilator synchrony
Eligibility Criteria
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
Sites / Locations
- Nanjing Zhong-Da Hospital, Southeast University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PSV ventilation
NAVA ventilation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
trigger work of breathing
Secondary Outcome Measures
patient-ventilator synchrony
Full Information
NCT ID
NCT02114567
First Posted
November 4, 2013
Last Updated
July 15, 2014
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT02114567
Brief Title
Is it Necessary to Set External PEEP in AECOPD Patients
Official Title
Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exacerbation Chronic Obstructive Pulmonary Disease
Keywords
AECOPD, work of breathing, patient-ventilator synchrony
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSV ventilation
Arm Type
Experimental
Arm Description
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.
Arm Title
NAVA ventilation
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
PEEP titration
Intervention Description
In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi
Primary Outcome Measure Information:
Title
trigger work of breathing
Time Frame
1 day
Secondary Outcome Measure Information:
Title
patient-ventilator synchrony
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ling liu, md
Organizational Affiliation
Department of Critical Care Medicine, Nanjing Zhongda Hospital and School of Medicine, Southeast University, China
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Zhong-Da Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26059238
Citation
Liu L, Xia F, Yang Y, Longhini F, Navalesi P, Beck J, Sinderby C, Qiu H. Neural versus pneumatic control of pressure support in patients with chronic obstructive pulmonary diseases at different levels of positive end expiratory pressure: a physiological study. Crit Care. 2015 Jun 9;19(1):244. doi: 10.1186/s13054-015-0971-0.
Results Reference
derived
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Is it Necessary to Set External PEEP in AECOPD Patients
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