Is it Necessary to Set External PEEP in AECOPD Patients

NCT02114567 | Completed DMC

• 1 other identifier: COPDNAVA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Conditions

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Keywords

AECOPD; work of breathing; patient-ventilator synchrony

Outcome Measures

Primary Outcomes (1)

• trigger work of breathing

  1 day

Secondary Outcomes (1)

• patient-ventilator synchrony

  1 day

Study Arms (2)

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.

Other: PEEP titration

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.

Other: PEEP titration

Interventions

PEEP titration OTHER

In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi

NAVA ventilation; PSV ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhong-Da Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 26059238 DERIVED

Study Officials

• ling liu, md

  Department of Critical Care Medicine, Nanjing Zhongda Hospital and School of Medicine, Southeast University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: April 15, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

CN (1)