Skip to main content
OpenTrials
Completed

NCT Number: NCT05207267

Driving Pressure Guided VT in ARDS Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ling Liu

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥ 18 years old
  • admitted to intensive care unit with a moderate to severe ARDS
  • invasive mechanical ventilation

Exclusion criteria

  • contraindications for prone position ventilation
  • Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
  • New York Heart Association class above II
  • gave written or witnessed verbal informed consent.
  • 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)
  • Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).

Treatment and study plan

driving pressure guided tidal volume

Device

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.

Primary outcomes

  1. regional compliance using EIT

    Time frame: Day 1

    regional compliance using EIT

  2. regional ventilation

    Time frame: Day 1

    regional ventilation using EIT

  3. regional perfusion

    Time frame: Day 1

    regional perfusion using EIT

  4. Region-ventilation-delay

    Time frame: Day 1

    Region-ventilation-delay using EIT

  5. driving pressure

    Time frame: Day 3

    measurement as one index of respiratory compliance

  6. the number of regional lung ventilation

    Time frame: Day 3

    regional ventilation measuring by EIT

  7. the number of regional lung perfusion

    Time frame: Day 3

    regional perfusion measuring by EIT

  8. the number of region-ventilation-delay (RVD)

    Time frame: Day 3

    the RVD measuring by EIT

Secondary outcomes

  1. Value of ventilation-perfusion (V/Q) mismatch

    Time frame: Day 1

    V/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).

  2. Value of ventilation-perfusion (V/Q) mismatch

    Time frame: Day 3

    V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated

  3. Value of ventilation-perfusion (V/Q) mismatch

    Time frame: Day 7

    V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated

  4. The Global Inhomogeneity (GI) index

    Time frame: Day 1

    higher values indicating less homogenous ventilation

  5. The Global Inhomogeneity (GI) index

    Time frame: Day 3

    higher values indicating less homogenous ventilation

  6. The Global Inhomogeneity (GI) index

    Time frame: Day 7

    higher values indicating less homogenous ventilation

  7. Blood gas

    Time frame: Day 1

    PaO2

  8. Ventilation free day

    Time frame: Day 28

    ventilation free day in day 28

  9. 28 day mortality

    Time frame: Day 28

    death in day 28

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.