NCT00969605

Brief Summary

Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Last Updated

May 27, 2010

Status Verified

September 1, 2009

Enrollment Period

1.1 years

First QC Date

August 31, 2009

Last Update Submit

May 26, 2010

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

weaningadaptive support ventilationCOPD

Outcome Measures

Primary Outcomes (1)

  • Weaning duration

Secondary Outcomes (2)

  • Weaning success

  • Length of stay in the ICU

Study Arms (2)

Pressure support ventilation

ACTIVE COMPARATOR
Procedure: Comparison of two different modes for weaning from mechanical ventilation

Adaptive support ventilation

ACTIVE COMPARATOR
Procedure: Comparison of two different modes for weaning from mechanical ventilation

Interventions

Comparison of two different modes for weaning from mechanical ventilationPROCEDURE

Chronic obstructive pulmonary disease patients under mechanical ventilation were randomized to adaptive or pressure support ventilation modes when they met the weaning criteria.

Also known as: weaning protocol
Adaptive support ventilationPressure support ventilation

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of COPD
  • On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure

You may not qualify if:

  • Mechanical ventilation less then 24 hours (self extubation or death),
  • Having a tracheotomy and
  • COPD coexisted with severe cardiac or neurologic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit

Izmir, 35210, Turkey (Türkiye)

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

  • Cenk Kirakli, MD

    Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

April 1, 2007

Primary Completion

May 1, 2008

Study Completion

December 1, 2008

Last Updated

May 27, 2010

Record last verified: 2009-09

Locations

TU(1)