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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intellivent ASV | Experimental | Patients in this arm will be ventilated with Intellivent ASV. Intellivent ASV is an automatic close loop ventilation mode. FiO2 setting will be automatically adjusted according to patients SpO2 and minute volume will be automatically adjusted according to patients EtCO2. |
|
| PCV+PSV | No Intervention | PCV+PSV is a conventional ventilation strategy of pressure controlled ventilation PCV) and pressure support ventilation (PSV).In this arm, FiO2, pressure control levels, respiratory frequency and all the ventilator settings will be manually adjusted by the physicians in charge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intellivent ASV | Device | Automated Invasive mechanical ventilation and weaning strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of intubation | Time from intubation until extubation | 24th month |
| Duration of mechanical ventilation (NIV included) | Total time patient remains on mechanical ventilation support (invasive or noninvasive) | 24th month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of manual settings | Number of adjusments made manually to set the ventilator | 24th month |
| Number of blood gas analysis tests | Number of arterial blood gas tests under mechanical ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilknur Naz | Izmir Chest Diseases and Surgery Training Hospital | Principal Investigator |
| Burcu CINLETI | Izmir Chest Diseases and Surgery Training Hospital | Principal Investigator |
| Huseyin OZKARAKAS | Izmir Chest Diseases and Surgery Training Hospital | Principal Investigator |
| Tunzala YAVUZ | Izmir Chest Diseases and Surgery Training Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit | Izmir | 35210 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 24th month |
| Weaning duration | Time from the beginning of weaning until extubation | 24th month |
| Time spent on spontaneous ventilation | Time patient actively triggers the ventilator | 24th month |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |