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Completed

NCT Number: NCT02651935

Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Izmir, 35210, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • ARDS
  • Broncho-pleural fistula

Treatment and study plan

Intellivent ASV

Device

Automated Invasive mechanical ventilation and weaning strategy

Primary outcomes

  1. Duration of intubation

    Time frame: 24th month

    Time from intubation until extubation

  2. Duration of mechanical ventilation (NIV included)

    Time frame: 24th month

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

Secondary outcomes

  1. Number of manual settings

    Time frame: 24th month

    Number of adjusments made manually to set the ventilator

  2. Number of blood gas analysis tests

    Time frame: 24th month

    Number of arterial blood gas tests under mechanical ventilation

  3. Weaning duration

    Time frame: 24th month

    Time from the beginning of weaning until extubation

  4. Time spent on spontaneous ventilation

    Time frame: 24th month

    Time patient actively triggers the ventilator

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2016
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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