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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIzmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Restrictive lung pathologies

Impaired hemodynamic status

Esophageal pathologies

Bronchopleural fistula

Trial design

Design model

Crossover

Treatments tested in this trial

  • Minute volume target of 100%

    Other intervention

    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 intervention

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

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: 1.1. ASV, MV target 100%Experimental treatment 1 intervention
Group B: 1.2. Volume control, MV target %100Active comparator 1 intervention
Group C: 2.1. ASV, MV target to reach PaCO2< 45 mmHgExperimental treatment 1 intervention
Group D: 2.2. Volume control, MV target to reach PaCO2< 45 mmHgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Transpulmonary inspiratory pressure (Ptinsp)

Ptpinsp will be measured with an inspiratory pause maneuver.

Time frame
30'th minute of each intervention arm

Secondary outcomes

1

Intrinsic Positive End Expiratory Pressure (PEEPi)

PEEPi will be measured with an expiratory hold maneuver.

Time frame
30'th minute of each intervention arm

Other outcomes

1

Mean arterial pressure

Mean arterial pressure measured by invasive or non-invasive methods

Time frame
30'th minute of each intervention arm
2

PaO2, FiO2 ratio

Ratio of arterial partial oxygen pressure to inspired fraction of oxygen

Time frame
30'th minute of each intervention arm
3

Heart rate

Heart rate measured by ECG

Time frame
30'th minute of each intervention arm

Sponsors and contacts

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