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Clinical Trials/NCT02651935
NCT02651935
Completed
N/A

A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital1 site in 1 country88 target enrollmentAugust 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Enrollment
88
Locations
1
Primary Endpoint
Duration of intubation
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.

Detailed Description

COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
February 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Cenk Kirakli, M.D.

Associate Professor, Pulmonary and Critical Care Medicine

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

Eligibility Criteria

Inclusion Criteria

  • COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)
  • Age \> 18 years
  • Written and/or informed consent

Exclusion Criteria

  • Septic shock
  • Tracheostomy and/or home mechanical ventilation
  • Expected poor short term prognosis
  • Cardiac arrest with a poor neurological prognosis
  • Broncho-pleural fistula

Outcomes

Primary Outcomes

Duration of intubation

Time Frame: 24th month

Time from intubation until extubation

Duration of mechanical ventilation (NIV included)

Time Frame: 24th month

Total time patient remains on mechanical ventilation support (invasive or noninvasive)

Secondary Outcomes

  • Weaning duration(24th month)
  • Time spent on spontaneous ventilation(24th month)
  • Number of manual settings(24th month)
  • Number of blood gas analysis tests(24th month)

Study Sites (1)

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