Dynamic Non-invasive Monitoring of Inspiratory Effort
Dynamic Analysis of Inspiratory Effort Using Non-invasive Monitoring as a Predictor of Liberation From Invasive Mechanical Ventilation Starting From the Transition Phase to Assisted Spontaneous Ventilation: a Prospective Observational Cohort Study Using Multivariate Joint Modeling and a Bayesian Approach
This prospective, observational cohort study aims to evaluate whether the dynamic monitoring of a patient's breathing effort can predict successful liberation from invasive mechanical ventilation. The study will include 120 patients who have undergone 36 hours or more of controlled mechanical ventilation and deep sedation. Patient monitoring will commence immediately upon their transition to an assisted spontaneous breathing mode with pressure support. Starting from this clinical milestone, the researchers will track the patients' longitudinal inspiratory effort daily through four specific variables: maximum occlusion pressure, muscle pressure index, flow index via visual waveform inspection, and diaphragmatic thickening fraction via ultrasound. Concurrently, ventilator safety parameters (plateau pressure, driving pressure, transpulmonary pressure, and compliance) will be recorded. The primary outcome is the time from PSV initiation to successful weaning (defined as 72 hours without ventilator support). Clinical events such as death or return to a controlled mode due to PSV failure will be statistically treated as competing risks. Secondary outcomes include the incidence of pneumonia, ICU-acquired weakness, delirium, mortality, and PSV failure. Data will be analyzed using multivariate joint modeling within a Bayesian framework.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jacinto Espeleta Hernández, MD
- Numer telefonu: +34685814532
- E-mail: jacinto.espeleta@ssib.es
Lokalizacje studiów
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Hiszpania, 07120
- Rekrutacyjny
- Department of Intensive Care Medicine, Hospital Universitario Son Espases
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Kontakt:
- Jacinto Espeleta Hernández, MD
- Numer telefonu: +34685814532
- E-mail: jacinto.espeleta@ssib.es
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Adult patients admitted to Intensive Care Unit who require invasive mechanical ventilation due to any cause with 36 hours or more with a controlled mode of mechanical ventilation and deep sedation
Opis
Inclusion Criteria:
- 18 years old or more.
- Patients undergoing invasive mechanical ventilation for any cause under a controlled ventilation mode for more than 36 hours.
- Attending physician's decision to initiate pressure support ventilation according to standard clinical practice.
Exclusion Criteria:
- Pregnancy.
- Degenerative neuromuscular disease (e.g., amyotrophic lateral sclerosis, congenital myopathies).
- Air leak/fistula that prevents breathing-pause maneuvers.
- Diaphragmatic paralysis.
- Limitation of life-sustaining treatment in case of weaning failure.
- Conditions preventing follow-up up to 72 hours after liberation from mechanical ventilation.
- Use of neuromuscular blocking agents within the last 24 hours.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily Inspiratory Effort: diaphragmatic thickening fraction.
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using diaphragmatic thickening fraction measured via ultrasound. Unit of measure: percentage (%). |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Daily Inspiratory Effort: pressure muscle index
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using the pressure muscle index measured in the mechanical ventilator during an end-inspiratory occlusion maneuver. Unit of measure: centimeters of water |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Daily Inspiratory Effort: maximum occlusion pressure
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using the maximum occlusion pressure measured in the mechanical ventilator during an end-espiratory occlusion maneuver. Unit of measure: centimeters of water |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Daily Inspiratory Effort: flow index
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Non-invasive monitoring of patient inspiratory effort performed daily starting from the initiation of pressure support ventilation using a qualitative evaluation by analyzing the airway flow waveform on the mechanical ventilator. The profile is categorized daily as positive (presence of effort) or negative (absence of effort). For reporting and analytical purposes, this qualitative assessment is coded as a binary scale where 0 indicates a negative flow index and 1 indicates a positive flow index. Individual daily data trajectories will be analyzed using a Bayesian joint model. Unit of measure: score on a scale, where 0 represents negative flow index and 1 represents a positive flow index |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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incidence of Ventilator-Associated Pneumonia
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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proportion of patients who develop ventilator-associated pneumonia based on standard clinical, radiological, and microbiological criteria. |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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incidence of Intensive Care Unit-Acquired Weakness
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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development of critical illness weakness evaluated via the Medical Research Council score, which evaluates 6 muscle groups bilaterally, ranging from a total score of 0 (no strength) to 60 (normal muscle strength), where higher scores indicate better muscle strength. Intensive Care Unit-Acquired Weakness will be defined as an MRC sum score of 48 or less. |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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incidence of delirium
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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daily screening for delirium using the Confusion Assessment Method for the Intensive Care Unit, which assesses four features: (1) acute onset or fluctuating course, (2) inattention, (3) altered level of consciousness, and (4) disorganized thinking. Delirium is defined as positive when features 1 and 2, and either feature 3 or 4 are present. |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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incidence of mortality
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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incidence of death by any cause during the study period (handled as a competing risk in the main analysis). |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, return to a controlled ventilation mode for more than 6 hours, death or tracheostomy, assessed up to 28 days.
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Return to controlled mode of mechanical ventilation
Ramy czasowe: Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, death or tracheostomy, assessed up to 28 days.
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proportion of patients requiring a return to a controlled mechanical ventilation mode due to pressure support ventilation failure before achieving weaning |
Measured daily from the initiation of pressure support ventilation until the occurrence of successful liberation from mechanical ventilation, death or tracheostomy, assessed up to 28 days.
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Jacinto Espeleta Hernández, MD, Hospital Son Espases
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- GOIBE226790
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
individual participant data will not be share outside the core research team to ensure strict patient confidentiality and comply with local data protection regulations
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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