Driving Pressure Guided VT in ARDS Patients

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

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.

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Device: driving pressure guided tidal volume

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Ling Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: testing arm; ventilated with different VT using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany)	Device: driving 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
regional compliance using EIT	regional compliance using EIT	Day 1
regional ventilation	regional ventilation using EIT	Day 1
regional perfusion	regional perfusion using EIT	Day 1
Region-ventilation-delay	Region-ventilation-delay using EIT	Day 1
driving pressure	measurement as one index of respiratory compliance	Day 3
the number of regional lung ventilation	regional ventilation measuring by EIT	Day 3
the number of regional lung perfusion	regional perfusion measuring by EIT	Day 3
the number of region-ventilation-delay (RVD)	the RVD measuring by EIT	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of ventilation-perfusion (V/Q) mismatch	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).	Day 1
Value of ventilation-perfusion (V/Q) mismatch	V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated	Day 3
Value of ventilation-perfusion (V/Q) mismatch	V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated	Day 7
The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 1
The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 3
The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 7
Blood gas	PaO2	Day 1
Ventilation free day	ventilation free day in day 28	Day 28
28 day mortality	death in day 28	Day 28

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Ling Liu, Zhongda Hospital, School of Medicine, Southeast Univerty

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: ARDS; ventilation and perfusion matching; ventilation inhomogeneity
• Other Study ID Numbers: Ling-driving pressure

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: by email
• IPD Sharing Time Frame: with in two years after publication
• IPD Sharing Access Criteria: other researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No