Phenotype-Guided Weaning in Mechanically Ventilated Patients With Chronic Comorbidities
17. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1380
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yang Li, MD
- Telefonnummer: +8615651782917
- E-post: liyangseu@yeah.net
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of 28-Day Ventilator-Free Days
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Intensive Care Unit or Hospital Mortality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ling Liu, PHD, Zhongda Hospital, School of Medicine, Southeast University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. november 2027
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
12. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Phenotype-Weaning-Chronic
Plan for individuelle deltakerdata (IPD)
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