Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Intellivent ASV

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35210
    • Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Intellivent ASV; Automated Invasive mechanical ventilation and weaning strategy
No Intervention: PCV+PSV; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: critical care; weaning; Respiration, Artificial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IGHCEAH-ICU-3