Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities

Summary

The goal of this clinical trial is to learn whether a phenotype-guided weaning strategy can help adults with chronic comorbidities be liberated from invasive mechanical ventilation earlier. It will also learn about the safety of this strategy.

The main questions it aims to answer are:

* Does the phenotype-guided weaning strategy increase the number of ventilator-free days within 28 days after enrollment?
* Does the strategy improve the process and success of ventilator liberation?
* What safety events occur when this strategy is used?

Researchers will compare the phenotype-guided weaning strategy with standard care in mechanically ventilated patients with chronic cardiovascular, cerebrovascular, or respiratory comorbidities.

In the intervention period, participants will receive a protocolized ventilator weaning pathway. This pathway includes assisted ventilation transition, daily weaning readiness screening, a 0 cmH2O continuous positive airway pressure test, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support when appropriate.

The phenotype-guided part of the strategy is mainly used for participants who fail a spontaneous breathing trial or have difficult weaning. These participants will undergo structured ABCDE screening to identify the main phenotype or mechanism of weaning failure:

* A: airway or lung dysfunction
* B: brain dysfunction, including delirium, anxiety, agitation, or impaired consciousness
* C: cardiac dysfunction
* D: diaphragm or respiratory muscle dysfunction
* E: endocrine, metabolic, or nutritional problems

Based on the identified phenotype, clinicians will provide targeted assessment and treatment. Participants will be followed for ventilator-free days through day 28 and for clinical outcomes through day 90.

Conditions

• Mechanical Ventilation Weaning
• Chronic Disease

Interventions

OTHER

Phenotype-Guided Weaning Strategy

A protocolized phenotype-guided strategy for ventilator liberation. The pathway includes assisted ventilation transition, daily weaning readiness screening, a 0 cmH2O continuous positive airway pressure test, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support when appropriate. The key phenotype-guided component is applied to participants with spontaneous breathing trial failure or difficult weaning. These participants undergo structured ABCDE screening to identify the dominant mechanism of weaning failure: A, airway or lung dysfunction; B, brain dysfunction; C, cardiac dysfunction; D, diaphragm or respiratory muscle dysfunction; and E, endocrine, metabolic, or nutritional problems. Targeted evaluation and treatment are then provided according to the identified phenotype.

OTHER

Standard Care

Usual mechanical ventilation and weaning management according to each center's routine clinical practice and current guidelines. The treating clinical team determines ventilator settings, weaning readiness assessment, spontaneous breathing trial, extubation assessment, post-extubation respiratory support, and related supportive care.

Sponsors & Collaborators

• Southeast University, China

  lead OTHER

Principal Investigators

• Ling Liu, phD · Zhongda Hospital, School of Medicine, Southeast University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2027-09-30

Completion

2027-11-30