Driving Pressure Guided VT in ARDS Patients

• Sponsor: Southeast University, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05207267
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Device: driving pressure guided tidal volume	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. regional compliance using EIT [Day 1]

   regional compliance using EIT

2. regional ventilation [Day 1]

   regional ventilation using EIT

3. regional perfusion [Day 1]

   regional perfusion using EIT

4. Region-ventilation-delay [Day 1]

   Region-ventilation-delay using EIT

5. driving pressure [Day 3]

   measurement as one index of respiratory compliance

6. the number of regional lung ventilation [Day 3]

   regional ventilation measuring by EIT

7. the number of regional lung perfusion [Day 3]

   regional perfusion measuring by EIT

8. the number of region-ventilation-delay (RVD) [Day 3]

   the RVD measuring by EIT

Secondary Outcome Measures

1. Value of ventilation-perfusion (V/Q) mismatch [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 [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 [Day 7]

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

4. The Global Inhomogeneity (GI) index [Day 1]

   higher values indicating less homogenous ventilation

5. The Global Inhomogeneity (GI) index [Day 3]

   higher values indicating less homogenous ventilation

6. The Global Inhomogeneity (GI) index [Day 7]

   higher values indicating less homogenous ventilation

7. Blood gas [Day 1]

   PaO2

8. Ventilation free day [Day 28]

   ventilation free day in day 28

9. 28 day mortality [Day 28]

   death in day 28

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. aged 18 to 80 years

2. admitted to intensive care unit with a confirmed diagnosis of ARDS

3. received mechanical ventilation less than 48 hours,

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ling Liu	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

• Southeast University, China

Investigators

• Study Director: Ling Liu, Zhongda Hospital, School of Medicine, Southeast Univerty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ling Liu, Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Southeast University, China
• ClinicalTrials.gov Identifier: NCT05207267
• Other Study ID Numbers: Ling-driving pressure
• First Posted: Jan 26, 2022
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ling Liu, Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Southeast University, China: ARDS; ventilation and perfusion matching; ventilation inhomogeneity

Study Results

No Results Posted as of Jan 26, 2022