Is it Necessary to Set External PEEP in AECOPD Patients | NCT02114567

Studies
Is it Necessary to Set External PEEP in AECOPD Patients

NCT02114567

Sponsor

Southeast University, China

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Interventions

PEEP titration

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Nov 4, 2013

First Submission Date that Met QC Criteria

Apr 14, 2014

First Posted Date

Apr 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PEEP titration	Other	In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi	NAVA ventilation PSV ventilation

Measure	Description	Time Frame
trigger work of breathing		1 day

Measure	Description	Time Frame
patient-ventilator synchrony		1 day

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ling liu, md	Department of Critical Care Medicine, Nanjing Zhongda Hospital and School of Medicine, Southeast University, China	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Zhong-Da Hospital, Southeast University		Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26059238	Derived	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.