Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651935
• Other study ID #: IGHCEAH-ICU-3
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 2019

Study information

• Verified date: July 2021
• Source: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Intellivent ASV
Automated Invasive mechanical ventilation and weaning strategy

Locations

Country	Name	City	State
Turkey	Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit	Izmir

Sponsors (1)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of intubation	Time from intubation until extubation	24th month
Primary	Duration of mechanical ventilation (NIV included)	Total time patient remains on mechanical ventilation support (invasive or noninvasive)	24th month
Secondary	Number of manual settings	Number of adjusments made manually to set the ventilator	24th month
Secondary	Number of blood gas analysis tests	Number of arterial blood gas tests under mechanical ventilation	24th month
Secondary	Weaning duration	Time from the beginning of weaning until extubation	24th month
Secondary	Time spent on spontaneous ventilation	Time patient actively triggers the ventilator	24th month