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Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities

17 maggio 2026 aggiornato da: Ling Liu, Southeast University, China

Effect of a Phenotype-Guided Precision Intervention Strategy on 28-Day Ventilator-Free Days in Mechanically Ventilated Patients With Chronic Comorbidities: A Multicenter Open-Label Randomized Controlled Trial

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1380

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Age 18 years or older.
  2. Presence of at least one chronic cardiovascular, cerebrovascular, or respiratory comorbidity. Cardiovascular and cerebrovascular comorbidities include stroke, hypertension, ischemic heart disease, valvular heart disease, heart failure, pulmonary heart disease, cardiomyopathy, and arrhythmia. Respiratory comorbidities include chronic obstructive pulmonary disease, asthma, bronchitis, emphysema, interstitial lung disease, and pneumoconiosis. These conditions will be identified according to the International Classification of Diseases 11th Revision diagnosis codes.
  3. Receiving invasive mechanical ventilation for at least 24 hours and expected to require mechanical ventilation for at least 72 hours.
  4. Not receiving neuromuscular blocking agents and having a Richmond Agitation-Sedation Scale score of -3 or higher.
  5. PaO2/FiO2 of 150 mmHg or higher.

Exclusion Criteria:

  1. Severe neuromuscular disease, such as Guillain-Barre syndrome, myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, or high spinal cord injury.
  2. Severe dysfunction of other organs with expected death in the short term.
  3. Severe end-stage irreversible respiratory, cardiac, neurological, or malignant disease, or receiving palliative care.
  4. Pregnancy.
  5. Participation in another clinical study.
  6. Written informed consent not provided.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Phenotype-Guided Weaning Strategy
During the intervention period, participants receive standard intensive care plus a protocolized phenotype-guided weaning strategy. The strategy 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. For participants who fail a spontaneous breathing trial or have difficult weaning, structured ABCDE screening is used to identify the dominant phenotype of weaning failure, including airway or lung dysfunction, brain dysfunction, cardiac dysfunction, diaphragm or respiratory muscle dysfunction, and endocrine, metabolic, or nutritional problems. Targeted management is provided according to the identified phenotype.
Altro: 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.
Comparatore attivo: Standard Care
During the control period, participants receive usual mechanical ventilation and weaning management according to each center's routine clinical practice and current guidelines. Management may include ventilator mode and parameter adjustment, treatment of underlying disease and complications, analgesia and sedation, fluid and hemodynamic management, nutrition, early mobilization and rehabilitation, airway management, weaning readiness assessment, spontaneous breathing trial, extubation assessment, and post-extubation respiratory support as determined by the treating clinical team.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of 28-Day Ventilator-Free Days
Lasso di tempo: From enrollment to day 28
Ventilator-free days are defined as the number of days within 28 days after enrollment during which the participant is alive and free from invasive mechanical ventilation for at least 24 consecutive hours. Participants who die before day 28 or who remain mechanically ventilated at day 28 will be assigned zero ventilator-free days.
From enrollment to day 28

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Intensive Care Unit or Hospital Mortality
Lasso di tempo: Day 28 and day 90 after enrollment
Intensive care unit mortality and hospital mortality will be assessed at day 28 and day 90 after enrollment.
Day 28 and day 90 after enrollment
Time From Enrollment to Successful Weaning
Lasso di tempo: From enrollment to day 28
Time from enrollment to successful weaning. For intubated participants, successful weaning is defined as no death or reintubation within 7 days after extubation, or discharge from the intensive care unit within 7 days without invasive mechanical ventilation, whichever occurs first. For tracheostomized participants, successful weaning is defined as 7 consecutive days of spontaneous breathing through the tracheostomy without any mechanical ventilation, or discharge while breathing spontaneously, whichever occurs first.
From enrollment to day 28
Number of Participants in Each Weaning Outcome Category
Lasso di tempo: From enrollment to day 28
Participants will be classified into weaning outcome categories, including successful weaning, no weaning attempt, short weaning, difficult weaning, prolonged weaning success, and prolonged weaning failure.
From enrollment to day 28

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Southeast University, China

Investigatori

  • Investigatore principale: Ling Liu, PHD, Zhongda Hospital, School of Medicine, Southeast University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2027

Completamento dello studio (Stimato)

1 novembre 2027

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

18 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Phenotype-Weaning-Chronic

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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