NCT00568100

Brief Summary

The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2.3 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

4.6 years

First QC Date

December 4, 2007

Last Update Submit

April 27, 2015

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

gas exchangepressure support ventilationrespiratory mechanicsCOPDNAVA

Outcome Measures

Primary Outcomes (1)

  • Respiratory mechanics, gas exchange, work of breathing

    5 minutes

Secondary Outcomes (1)

  • Comfort of breathing

    5 minutes

Study Arms (1)

1

EXPERIMENTAL

COPD patients

Procedure: PSV and NAVA

Interventions

PSV and NAVAPROCEDURE

evaluated the effect of PSV and NAVA on breathing pattern, respiratory effort, gas exchange and level of breathing comfort in COPD patients

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable COPD patients during non invasive mechanical ventilation

You may not qualify if:

  • Haemodynamic instability
  • Coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

April 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)