Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

NCT ID: NCT02651935

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intellivent ASV

Intervention Type DEVICE

Automated Invasive mechanical ventilation and weaning strategy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intellivent ASV

Automated Invasive mechanical ventilation and weaning strategy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Cenk Kirakli, M.D.

Associate Professor, Pulmonary and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilknur Naz

Role: PRINCIPAL_INVESTIGATOR

Izmir Chest Diseases and Surgery Training Hospital

Burcu CINLETI

Role: PRINCIPAL_INVESTIGATOR

Izmir Chest Diseases and Surgery Training Hospital

Huseyin OZKARAKAS

Role: PRINCIPAL_INVESTIGATOR

Izmir Chest Diseases and Surgery Training Hospital

Tunzala YAVUZ

Role: PRINCIPAL_INVESTIGATOR

Izmir Chest Diseases and Surgery Training Hospital

Locations

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

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IGHCEAH-ICU-3

Identifier Type: -

Identifier Source: org_study_id

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