## Protocol Section
### Identification Module
**NCT ID:** NCT06424314

**Brief Title:** Exploration of Mechanisms for Weaning Failure

**Official Title:** Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal

#### Organization Study ID Info
**ID:** 202220252311
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The First Affiliated Hospital of Guangzhou Medical University

#### Responsible Party

**Investigator Affiliation:** The First Affiliated Hospital of Guangzhou Medical University

**Investigator Full Name:** Guan Lili

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study is a prospective physiologic study. The primary study population will be adult invasive tracheal intubated patients with COPD, and investigators will collect relevant demographic data, vital signs, and baseline physiologic parameters of the patients prior to the spontaneous breathing test（SBT).

The participants will be divided into a successful withdrawal group and a failed withdrawal group according to the SBT outcome, and the changes in the above parameters during SBT will be compared between the two groups .

**Detailed Description:** This observational study mainly include participants who had invasive mechanical ventilation for ≥48 h and are assessed to be ready for the SBT trial.The SBT approach is based on the low-level pressure support mode.

Prior to the SBT trial, baseline demographic and physiologic data of the participants will be collected, and the participants will be divided into two groups based on the results of the SBT trial: successful and unsuccessful, and the physiologic changes during the SBT trial will be compared between the two groups, respectively.

### Conditions Module

**Conditions:**

- Weaning Failure

- Central Respiratory Depression

- Diaphragm Injury

- Phrenic Nerve Disorder

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation

**Intervention Names:**

- Diagnostic Test: Monitoring of respiratory mechanics parameters

**Label:** weaning success

#### Arm Group 2

**Description:** Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation

**Intervention Names:**

- Diagnostic Test: Monitoring of respiratory mechanics parameters

**Label:** weaning failure

### Interventions

#### Intervention 1

**Arm Group Labels:**

- weaning failure

- weaning success

**Description:** Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography

**Name:** Monitoring of respiratory mechanics parameters

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** passed SBT trial and weaning from mechanical ventilation success with no need of reintubation

**Measure:** weaning success

**Time Frame:** Day 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

* neuromuscular disease； not first attempt at SBT for weaning

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing weaning from mechanical ventilation；Hemodynamic stability

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dr_nickguan@163.com

**Name:** Lili Guan, MD & PhD

**Phone:** 020-81566675

**Role:** CONTACT

**Contact 2:**

**Email:** huangqiaoyun23@foxmail.com

**Name:** Qiaoyun Huang

**Phone:** 020-81566675

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Contacts:**

***Contact 1:***

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

- **Name:** Lili Guan, MD & PhD

- **Phone:** 020-81566675

- **Role:** CONTACT

***Contact 2:***

- **Email:** huangqiaoyun23@foxmail.com

- **Name:** Qiaoyun Huang

- **Phone:** 020-81566675

- **Role:** CONTACT

**Country:** China

**Facility:** The First Hospital of Guangzhou Medical University

**State:** Guangdong

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: HIGH

- As Found: Respiratory Depression

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012131

- Term: Respiratory Insufficiency

### Misc Info Module

- Version Holder: 2024-05-31
