Clinical trial NCT02114567: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Exacerbation Chronic Obstructive Pulmonary Disease
Keywords: AECOPD
work of breathing
patient-ventilator synchrony
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: trigger work of breathing
timeFrame: 1 day
Secondary outcomes:
measure: patient-ventilator synchrony
timeFrame: 1 day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhong-Da Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Nanjing Zhongda Hospital and School of Medicine, Southeast University, China
name: ling liu, md
role: STUDY_DIRECTOR
References:
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.