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Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02651935
Enrollment
88
Registered
2016-01-11
Start date
2015-08-31
Completion date
2019-02-28
Last updated
2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Respiration, Artificial, weaning, critical care

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.

Interventions

Automated Invasive mechanical ventilation and weaning strategy

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of intubation24th monthTime from intubation until extubation
Duration of mechanical ventilation (NIV included)24th monthTotal time patient remains on mechanical ventilation support (invasive or noninvasive)

Secondary

MeasureTime frameDescription
Number of manual settings24th monthNumber of adjusments made manually to set the ventilator
Number of blood gas analysis tests24th monthNumber of arterial blood gas tests under mechanical ventilation
Weaning duration24th monthTime from the beginning of weaning until extubation
Time spent on spontaneous ventilation24th monthTime patient actively triggers the ventilator

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026