## Protocol Section
### Identification Module
**NCT ID:** NCT06393179

**Brief Title:** Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients

**Official Title:** Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients

#### Organization Study ID Info
**ID:** OPEN-RESPIRATORY
#### Organization
**Class:** OTHER
**Full Name:** Southeast University, China
### Status Module
#### Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-27
**Study First Submit QC Date:** 2024-04-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Southeast University, China

#### Responsible Party

**Investigator Affiliation:** Southeast University, China

**Investigator Full Name:** Ling Liu

**Investigator Title:** Director of Intensive Care Unit, Principal Investigator, Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.

### Conditions Module

**Conditions:**

- Mechanical Ventilation Pressure High

- Critical Illness

**Keywords:**

- mechanical ventilation

- airway closure

- alveolar collapse

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Enrolled patients will receive a PV curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure.

**Intervention Names:**

- Other: pressure-volume curve with a low-flow insufflation of 5 L/min

**Label:** P-V curve group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- P-V curve group

**Description:** The patient undergoes a pressure-volume curve with a low-flow insufflation of 5 L/min while in a state of analgesia, sedation, and absence of spontaneous breathing.

**Name:** pressure-volume curve with a low-flow insufflation of 5 L/min

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** airway closure and alveolar collapse are monitored by PV curve with a low-flow insufflation of 5 L/min

**Measure:** the rate of airway closure and alveolar collapse

**Time Frame:** up to 24 hours

**Description:** According to the characteristics of the low inflation point of PV curve, the respiratory open pressure phenotype was constructed

**Measure:** Phenotype of respiratory open pressure

**Time Frame:** up to 24 hours

#### Secondary Outcomes

**Description:** Respiratory system compliance is calculated as the ratio of tidal volume to the difference between plateau pressure and positive end-expiratory pressure.

**Measure:** respiratory system compliance

**Time Frame:** up to 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients undergoing controlled mechanical ventilation
* The duration of endotracheal intubation \< 48 hrs

Exclusion Criteria:

* Severe hemodynamic instability
* Severe chronic lung disease requiring long-term home oxygen therapy
* Patients without analgesic sedation
* Decline to participate in the study
* Refusal to sign informed consent

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** liulingdoctor@126.com

**Name:** ling liu, phD

**Phone:** 15901599659

**Role:** CONTACT

**Contact 2:**

**Email:** 18826401594@163.com

**Name:** xueyan yuan, phD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nanjing

**Country:** China

**Facility:** Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

**State:** Jiangsu

**Zip:** 210000

#### Overall Officials

**Official 1:**

**Affiliation:** Zhongda Hospital

**Name:** ling liu

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016638

- Term: Critical Illness

### Misc Info Module

- Version Holder: 2024-05-24
