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Is it Necessary to Set External PEEP in AECOPD Patients

S

Southeast University, China

Status

Completed

Conditions

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Treatments

Other: PEEP titration

Study type

Interventional

Funder types

Other

Identifiers

NCT02114567
COPDNAVA

Details and patient eligibility

About

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)

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

PSV ventilation
Experimental group
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.
Treatment:
Other: PEEP titration
NAVA ventilation
Experimental group
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.
Treatment:
Other: PEEP titration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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