Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Intellivent ASV

• Registration Number: NCT02651935
• Lead Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2015-02-06
• Study Start: 2015-08
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intellivent ASV	Intellivent ASV	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.

Primary Outcome Measures

Name	Time	Method
Duration of intubation	24th month	Time from intubation until extubation
Duration of mechanical ventilation (NIV included)	24th month	Total time patient remains on mechanical ventilation support (invasive or noninvasive)

Secondary Outcome Measures

Name	Time	Method
Weaning duration	24th month	Time from the beginning of weaning until extubation
Time spent on spontaneous ventilation	24th month	Time patient actively triggers the ventilator
Number of manual settings	24th month	Number of adjusments made manually to set the ventilator
Number of blood gas analysis tests	24th month	Number of arterial blood gas tests under mechanical ventilation

Trial Locations

Locations (1)

Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit; 🇹🇷 Izmir, Turkey