Clinical trial NCT02651935: Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU
Official title: A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Respiration, Artificial
weaning
critical care
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* ARDS
* Broncho-pleural fistula

Primary outcomes:
measure: Duration of intubation
timeFrame: 24th month
measure: Duration of mechanical ventilation (NIV included)
timeFrame: 24th month
Secondary outcomes:
measure: Number of manual settings
timeFrame: 24th month
measure: Number of blood gas analysis tests
timeFrame: 24th month
measure: Weaning duration
timeFrame: 24th month
measure: Time spent on spontaneous ventilation
timeFrame: 24th month
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Study officials:
affiliation: Izmir Chest Diseases and Surgery Training Hospital
name: Ilknur Naz
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Chest Diseases and Surgery Training Hospital
name: Burcu CINLETI
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Chest Diseases and Surgery Training Hospital
name: Huseyin OZKARAKAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Chest Diseases and Surgery Training Hospital
name: Tunzala YAVUZ
role: PRINCIPAL_INVESTIGATOR
References: