Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04089111
Acronym
COPD-SAFE
Enrollment
20
Registered
2019-09-13
Start date
2024-12-31
Completion date
2025-02-28
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Mechanical ventilation, Adaptive Support Ventilation, Transpulmonary pressure, Intrinsic PEEP, Safety

Brief summary

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.

Detailed description

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.

Interventions

OTHERMinute volume target of 100%

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

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients will not be aware of the procedure or ventilation modes that will be performed. Outcomes will be analyzed by an independent statistician.

Intervention model description

Patients will be ventilated for two different minute volume targets in two sets. 'Adapted support ventilation' and 'volume control (VC)' modes will be used consecutively in each set. Every patient will be ventilated 1.1. ASV with minute volume target of % 100; 1.2. VC with same MV target; 2.1 ASV with MV target associated with PaCo2 less than 45 mmHg; 2.2 VC with same MV target. Sequence of ventilation modes wıll be randomized within each group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transpulmonary inspiratory pressure (Ptinsp)30'th minute of each intervention armPtpinsp will be measured with an inspiratory pause maneuver.

Secondary

MeasureTime frameDescription
Intrinsic Positive End Expiratory Pressure (PEEPi)30'th minute of each intervention armPEEPi will be measured with an expiratory hold maneuver.

Other

MeasureTime frameDescription
Mean arterial pressure30'th minute of each intervention armMean arterial pressure measured by invasive or non-invasive methods
PaO2, FiO2 ratio30'th minute of each intervention armRatio of arterial partial oxygen pressure to inspired fraction of oxygen
Heart rate30'th minute of each intervention armHeart rate measured by ECG

Countries

Turkey (Türkiye)

Contacts

Primary ContactSami C Kirakli, MD
samicenk.kirakli@sbu.edu.tr+905052352024
Backup ContactBurcu Acar Cinleti, MD
burcu_acar911@yahoo.com+905075022780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026