Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

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

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Intellivent ASV

Study type: Interventional

Funder types: Other

Identifiers

NCT02651935

IGHCEAH-ICU-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Intellivent ASV

Experimental group

Description:

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.

Treatment:

Device: Intellivent ASV

PCV+PSV

No Intervention group

Description:

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.