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

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Minute volume target of 100%; Other: Minute volume target to reach PaCO2 less than 45% (high tidal volume)

• Registration Number: NCT04089111
• Lead Sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-15
• Study Start: 2024-12
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1.2. Volume control, MV target %100	Minute volume target of 100%	Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3 Ventilation frequency will be adjusted to reach the same volume target calculated in arm1.
2.1. ASV, MV target to reach PaCO2< 45 mmHg	Minute volume target to reach PaCO2 less than 45% (high tidal volume)	Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator.
1.1. ASV, MV target 100%	Minute volume target of 100%	Patients will be ventilated with ASV mode. Tidal volume, ventilation frequency, inspiratory duration will be automatically adjusted by the mechanical ventilator.
2.2. Volume control, MV target to reach PaCO2< 45 mmHg	Minute volume target to reach PaCO2 less than 45% (high tidal volume)	Patients will be ventilated with volume control mode. A tidal volume of 6-8 ml/kg will be used. I:E ratio will be set as 1:3. Ventilation frequency will be adjusted to reach the target PaCO2 level

Primary Outcome Measures

Name	Time	Method
Transpulmonary inspiratory pressure (Ptinsp)	30'th minute of each intervention arm	Ptpinsp will be measured with an inspiratory pause maneuver.

Secondary Outcome Measures

Name	Time	Method
Intrinsic Positive End Expiratory Pressure (PEEPi)	30'th minute of each intervention arm	PEEPi will be measured with an expiratory hold maneuver.

Trial Locations

Locations (1)

Izmir Dr. Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit; 🇹🇷 Izmir, Yenisehir, Turkey