Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

NCT02651935 | Completed

• 1 other identifier: IGHCEAH-ICU-3
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Respiration, Artificial; weaning; critical care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of manual settings

  24th month

• Number of blood gas analysis tests

  24th month

• Weaning duration

  24th month

• Time spent on spontaneous ventilation

  24th month

Study Arms (2)

Intellivent ASV

EXPERIMENTAL

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

PCV+PSV

NO INTERVENTION

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.

Interventions

Intellivent ASV DEVICE

Automated Invasive mechanical ventilation and weaning strategy

Intellivent ASV

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Septic shock
• Tracheostomy and/or home mechanical ventilation
• Expected poor short term prognosis
• Cardiac arrest with a poor neurological prognosis
• ARDS
• Broncho-pleural fistula

Sponsors & Collaborators

• Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital: lead

Study Sites (1)

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

Izmir, 35210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: January 11, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

TU (1)