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NCT Number: NCT04089111

Closed Loop Ventilation With High Tidal Volumes and Safe Transpulmonary Pressure in COPD (COPD-SAFE)

This study evaluates the safety and efficacy of high tidal volumes generated by "Adapted Support Ventilation (ASV) mode' in mechanically ventilated severe COPD patients. Every patient will be ventilated consecutively with ASV and Volume Control (VC) modes at 2 different levels of minute volume in 2 sets. ASV mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Izmir, Yenisehir, 35550, Turkey (Türkiye)

About this study

Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) may require mechanical ventilation. Various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. High tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. Adapted Support Ventilation (ASV) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. Led by measured lung mechanics, ASV mode often generates higher than usual tidal volumes during mechanical ventilation of COPD patients, particularly if the minute volume (MV) target is high. Thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (Ptp), and whether Ptp stays within safe limits during ASV mode is of great interest.

Patients with acute exacerbation of COPD who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. All patients will be deeply sedated. An esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight.

Patients will be ventilated with two different MV targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively within each set. While the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients PaCO2 below 45 mmHg. The sequence of ventilation mode will be randomized within each set. Ventilation periods will be 30 minutes with 15 minutes washout period in between. İf Ptp increase above 20 cmH20 at any ventilation mode, the tidal volume will be decreased.

ASV mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as VC mode with lower intrinsic positive end expiratory pressure (iPEEP) levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute exacerbation of Chronic Obstructive Lung Disease
  • Being intubated for less than 24 hours
  • Not being planned to be extubated in 24 hours
  • Expiratory time constant (RCexp) more than > 2.0 s

Exclusion criteria

  • Restrictive lung pathologies
  • Impaired hemodynamic status
  • Esophageal pathologies
  • Bronchopleural fistula

Treatment and study plan

Minute volume target of 100%

Other

Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight).

Minute volume target to reach PaCO2 less than 45% (high tidal volume)

Other

Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%.

Primary outcomes

  1. Transpulmonary inspiratory pressure (Ptinsp)

    Time frame: 30'th minute of each intervention arm

    Ptpinsp will be measured with an inspiratory pause maneuver.

Secondary outcomes

  1. Intrinsic Positive End Expiratory Pressure (PEEPi)

    Time frame: 30'th minute of each intervention arm

    PEEPi will be measured with an expiratory hold maneuver.

Other outcomes

  1. Mean arterial pressure

    Time frame: 30'th minute of each intervention arm

    Mean arterial pressure measured by invasive or non-invasive methods

  2. PaO2, FiO2 ratio

    Time frame: 30'th minute of each intervention arm

    Ratio of arterial partial oxygen pressure to inspired fraction of oxygen

  3. Heart rate

    Time frame: 30'th minute of each intervention arm

    Heart rate measured by ECG

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu Acar Cinleti, MD

CONTACT

[email protected]

+905075022780

Sami C Kirakli, MD

CONTACT

[email protected]

+905052352024

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Does Automatically Generated Tidal Volumes With Closed-loop Ventilation Leads to Safe Transpulmonary Pressures in Intubated Chronic Obstructive Pulmonary Disease Patients?

Acronym: COPD-SAFE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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