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Driving Pressure Guided VT in ARDS Patients

Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05207267
Enrollment
57
Registered
2022-01-26
Start date
2021-06-30
Completion date
2022-12-30
Last updated
2023-08-24

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

Conditions

ARDS

Keywords

ARDS, ventilation and perfusion matching, ventilation inhomogeneity

Brief summary

A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.

Detailed description

Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany). Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2). Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase,the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected.

Interventions

DEVICEdriving pressure guided tidal volume

Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. aged ≥ 18 years old 2. admitted to intensive care unit with a moderate to severe ARDS 3. invasive mechanical ventilation

Exclusion criteria

1. contraindications for prone position ventilation 2. Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD) 3. New York Heart Association class above II 4. gave written or witnessed verbal informed consent. 5. Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician) 6. Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).

Design outcomes

Primary

MeasureTime frameDescription
the number of region-ventilation-delay (RVD)Day 3the RVD measuring by EIT
regional perfusionDay 1regional perfusion using EIT
Region-ventilation-delayDay 1Region-ventilation-delay using EIT
driving pressureDay 3measurement as one index of respiratory compliance
the number of regional lung ventilationDay 3regional ventilation measuring by EIT
the number of regional lung perfusionDay 3regional perfusion measuring by EIT
regional compliance using EITDay 1regional compliance using EIT
regional ventilationDay 1regional ventilation using EIT

Secondary

MeasureTime frameDescription
The Global Inhomogeneity (GI) indexDay 1higher values indicating less homogenous ventilation
Blood gasDay 1PaO2
Ventilation free dayDay 28ventilation free day in day 28
28 day mortalityDay 28death in day 28
Value of ventilation-perfusion (V/Q) mismatchDay 1V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026