Driving Pressure Guided VT in ARDS Patients

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207267
• Other study ID #: Ling-driving pressure
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• ARDS

Intervention

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.

Locations

Country	Name	City	State
China	Ling Liu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regional compliance using EIT	regional compliance using EIT	Day 1
Primary	regional ventilation	regional ventilation using EIT	Day 1
Primary	regional perfusion	regional perfusion using EIT	Day 1
Primary	Region-ventilation-delay	Region-ventilation-delay using EIT	Day 1
Primary	driving pressure	measurement as one index of respiratory compliance	Day 3
Primary	the number of regional lung ventilation	regional ventilation measuring by EIT	Day 3
Primary	the number of regional lung perfusion	regional perfusion measuring by EIT	Day 3
Primary	the number of region-ventilation-delay (RVD)	the RVD measuring by EIT	Day 3
Secondary	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
Secondary	Value of ventilation-perfusion (V/Q) mismatch	V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated	Day 3
Secondary	Value of ventilation-perfusion (V/Q) mismatch	V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated	Day 7
Secondary	The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 1
Secondary	The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 3
Secondary	The Global Inhomogeneity (GI) index	higher values indicating less homogenous ventilation	Day 7
Secondary	Blood gas	PaO2	Day 1
Secondary	Ventilation free day	ventilation free day in day 28	Day 28
Secondary	28 day mortality	death in day 28	Day 28