NCT00141440

Brief Summary

The investigators' aim is to study the effect of cycling off criteria during pressure support ventilation in COPD patients at two levels of PEEP and PSV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

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

Timeline
Completed

Started Jul 2005

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

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

December 30, 2009

Status Verified

September 1, 2008

Enrollment Period

1.7 years

First QC Date

August 31, 2005

Last Update Submit

December 29, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

gas exchangepressure support ventilationrespiratory mechanicsCOPD patients

Outcome Measures

Primary Outcomes (1)

  • Respiratory mechanics, gas exchange

    2 minutes

Secondary Outcomes (1)

  • Comfort of breathing

    2 minutes

Study Arms (1)

1

EXPERIMENTAL

COPD patients

Procedure: mechanical ventilation

Interventions

mechanical ventilationPROCEDURE

evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease

1

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable COPD patients during invasive mechanical ventilation

You may not qualify if:

  • Hemodynamic instability,
  • Paralysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Sacco

Milan, milano, 20100, Italy

Location

Related Publications (1)

  • Chiumello D, Polli F, Tallarini F, Chierichetti M, Motta G, Azzari S, Colombo R, Rech R, Pelosi P, Raimondi F, Gattinoni L. Effect of different cycling-off criteria and positive end-expiratory pressure during pressure support ventilation in patients with chronic obstructive pulmonary disease. Crit Care Med. 2007 Nov;35(11):2547-52. doi: 10.1097/01.CCM.0000287594.80110.34.

    PMID: 17893630RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • davide chiumello, md

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

  • Davide Chiumello, MD

    Policlinico

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

December 30, 2009

Record last verified: 2008-09

Locations

IT(1)