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Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intellivent ASV
Sponsored by
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Respiration, Artificial, weaning, critical care

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intellivent ASV

PCV+PSV

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2015
Last Updated
July 28, 2021
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02651935
Brief Title
Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU
Official Title
A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Respiration, Artificial, weaning, critical care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intellivent ASV
Arm Type
Experimental
Arm 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.
Arm Title
PCV+PSV
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intellivent ASV
Intervention Description
Automated Invasive mechanical ventilation and weaning strategy
Primary Outcome Measure Information:
Title
Duration of intubation
Description
Time from intubation until extubation
Time Frame
24th month
Title
Duration of mechanical ventilation (NIV included)
Description
Total time patient remains on mechanical ventilation support (invasive or noninvasive)
Time Frame
24th month
Secondary Outcome Measure Information:
Title
Number of manual settings
Description
Number of adjusments made manually to set the ventilator
Time Frame
24th month
Title
Number of blood gas analysis tests
Description
Number of arterial blood gas tests under mechanical ventilation
Time Frame
24th month
Title
Weaning duration
Description
Time from the beginning of weaning until extubation
Time Frame
24th month
Title
Time spent on spontaneous ventilation
Description
Time patient actively triggers the ventilator
Time Frame
24th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilknur Naz
Organizational Affiliation
Izmir Chest Diseases and Surgery Training Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burcu CINLETI
Organizational Affiliation
Izmir Chest Diseases and Surgery Training Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huseyin OZKARAKAS
Organizational Affiliation
Izmir Chest Diseases and Surgery Training Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tunzala YAVUZ
Organizational Affiliation
Izmir Chest Diseases and Surgery Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
City
Izmir
ZIP/Postal Code
35210
Country
Turkey

12. IPD Sharing Statement

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Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

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