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

NCT04089111 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Minute volume target of 100%

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

OTHER

Minute 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 & Collaborators

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

    lead OTHER

Principal Investigators

  • Sami C Kirakli, MD · Dr. Suat Seren Chest Diseases and Surgery Educatin and Resarch Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089111 on ClinicalTrials.gov