Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities
17 maja 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
1380
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yang Li, MD
- Numer telefonu: +8615651782917
- E-mail: liyangseu@yeah.net
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Age 18 years or older.
- 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.
- Receiving invasive mechanical ventilation for at least 24 hours and expected to require mechanical ventilation for at least 72 hours.
- Not receiving neuromuscular blocking agents and having a Richmond Agitation-Sedation Scale score of -3 or higher.
- PaO2/FiO2 of 150 mmHg or higher.
Exclusion Criteria:
- Severe neuromuscular disease, such as Guillain-Barre syndrome, myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, or high spinal cord injury.
- Severe dysfunction of other organs with expected death in the short term.
- Severe end-stage irreversible respiratory, cardiac, neurological, or malignant disease, or receiving palliative care.
- Pregnancy.
- Participation in another clinical study.
- Written informed consent not provided.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
|
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.
|
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Aktywny komparator: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of 28-Day Ventilator-Free Days
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants With Intensive Care Unit or Hospital Mortality
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Ling Liu, PHD, Zhongda Hospital, School of Medicine, Southeast University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
1 września 2027
Ukończenie studiów (Szacowany)
1 listopada 2027
Daty rejestracji na studia
Pierwszy przesłany
12 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 maja 2026
Pierwszy wysłany (Rzeczywisty)
18 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Phenotype-Weaning-Chronic
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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