## Protocol Section
### Identification Module
**NCT ID:** NCT06430554

**Brief Title:** Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability

**Official Title:** Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients

#### Organization Study ID Info
**ID:** 2024ZDSYLL044-P01
#### Organization
**Class:** OTHER
**Full Name:** Zhongda Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhongda Hospital

#### Responsible Party

**Investigator Affiliation:** Zhongda Hospital

**Investigator Full Name:** Fengmei Guo

**Investigator Title:** Director of Intensive Care Unit, Principal Investigator, Clinical Professor, Zhongda Hospital, Southeast University, China

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.

**Detailed Description:** Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability.

Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows:

Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team.

To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters.

EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).

### Conditions Module

**Conditions:**

- Respiratory Distress Syndrome

- Positive-Pressure Respiration

- Mechanical Ventilation

**Keywords:**

- Acute respiratory distress syndrome;Positive end expiratory pressure; Prone Position; Ventilation/perfusion matching.

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused

**Measure:** Ventilation-perfusion matching (V/Q match%)

**Time Frame:** Through study completion (within 24 hours)

#### Secondary Outcomes

**Description:** corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused

**Measure:** percentage of dead space

**Time Frame:** Through study completion (within 24 hours)

**Description:** corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused

**Measure:** percentage of shunt

**Time Frame:** Through study completion (within 24 hours)

**Description:** The compliance of respiratory system

**Measure:** Respiratory system compliance

**Time Frame:** Through study completion (within 24 hours)

**Description:** PaO2/FiO2 ratio

**Measure:** PaO2/FiO2 ratio

**Time Frame:** Through study completion (within 24 hours)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. age ≥18 years
2. Moderate-to-severe ARDS as per the 2023 ESICM definition
3. Undergoing invasive mechanical ventilation
4. Planned prone position based on the attending physicians' decisions
5. Signed informed consent

Exclusion Criteria:

1. age ≥85 years
2. Pregnancy
3. Severe hemodynamic instability (\> 30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min)
4. Clinically suspected elevated intracranial pressure (\>18 mm Hg)
5. Bronchopleural fistula
6. Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
7. Severe hypernatremia (\>170mmol/L)
8. Re-admission of patients already enrolled in this study, or patients who are participating in other studies

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Intubated mechanically ventilated ARDS patients.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fmguo2022@163.com

**Name:** Fengmei Guo, PhD, MD

**Phone:** +8613813841261

**Role:** CONTACT

**Contact 2:**

**Email:** 15505083904@163.com

**Name:** Zhiqian Zha, MM

**Phone:** +8615505083904

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nanjing

**Contacts:**

***Contact 1:***

- **Email:** fmguo2022@163.com

- **Name:** Fengmei Guo, Ph.D

- **Phone:** +8613813841261

- **Role:** CONTACT

**Country:** China

**Facility:** Zhongda Hospital, Southeast University

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 210009

#### Overall Officials

**Official 1:**

**Affiliation:** Nanjing Zhongda Hospital, Southeast University

**Name:** Fengmei Guo, PhD, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M28144

- Name: Acute Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

### Misc Info Module

- Version Holder: 2024-05-31
