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NCT02114567 Clinical Trial

Is it Necessary to Set External PEEP in AECOPD Patients

Acute Exacerbation Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02114567
Other study ID # COPDNAVA
Secondary ID
Status Completed
Phase N/A
First received November 4, 2013
Last updated July 15, 2014
Start date January 2014
Est. completion date June 2014

Study information
Verified date July 2014
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Nanjing Zhong-Da Hospital, Southeast University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary trigger work of breathing 1 day No
Secondary patient-ventilator synchrony 1 day No