- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07724392
Effect of High-Flow Humidified Oxygen on Ventilatory Work During the Spontaneous Breathing Trial (OTRAVAIL)
Weaning from mechanical ventilation (MV) accounts for a significant portion of the total MV duration, and failure to extubate or delayed extubation increases complications (particularly Ventilator-Associated Pneumonia (VAP)) and mortality. Standard tests (T-piece, Spontaneous Ventilation with Inspiratory Assistance (SV-IA)) have not demonstrated clear superiority, and the T-piece is still widely used despite its limitations. High-flow oxygen (HFO) may reduce ventilatory work and facilitate secretion clearance; however, there is a lack of physiological data in humans with an endotracheal tube in place. This study aims to address this gap prior to a subsequent clinical evaluation.
An experimental, prospective, single-center, 3-period crossover study with randomized sequence order and single-blind design (primary endpoint assessment and statistical analysis were conducted in a blinded manner).
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult patient, of legal age
- On invasive mechanical ventilation for more than 48 hours
With at least one criterion indicating a high risk of extubation failure:
- Age > 65 years
- Chronic respiratory disease
- Chronic cardiac disease
Capable of undergoing a mechanical ventilation weaning test ("weaning criterion"):
- Respiratory rate < 35 bpm
Adequate oxygenation:
- SpO₂ ≥ 90% with FiO₂ ≤ 40% and PEEP ≤ 8 cm H₂O
- Or PaO₂/FiO₂ ≥ 150 with PEEP ≤ 8 cm H₂O
- Effective cough
- Patient is alert (RASS score -2 to +1), without sedation
- Hemodynamically stable or on the minimum effective dose
- Patient has an invasive arterial pressure catheter for arterial blood sampling
- Informed consent signed by a family member
- Patient is enrolled in or eligible for a social security program
Exclusion Criteria:
- Resuscitation-associated neuromyopathy
- History of neuromuscular disease
- Admission for a neurological condition
- Subjects currently excluded from another study,
- Persons referred to in Articles L1121-5 through L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a health or social care facility for purposes other than research, minors, and persons subject to a legal protection order or unable to give informed consent).
- Staff members who report to the principal investigator
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: TP/HFO/PSV
T piece follow by HFO follow by PSV
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
Inny: TP/PSV/HFO
T piece follow by PSV follow by HFO
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
Inny: PSV/HFO/TP
PSV follow by HFO follow by T piece
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
Inny: PSV/TP/HFO
PSV follow by T piece follow by HFO
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
Inny: HFO/TP/PSV
HFO follow by T piece follow by PSV
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
|
Inny: HFO/PSV/TP
HFO follow by PSV follow by TP
|
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
The endotracheal tube will be connected to the pneumotachograph.
The ventilator settings will be adjusted as follows: VS mode, inspiratory support at 7 cmH₂O, PEEP at 0 cmH₂O.
The endotracheal tube will be disconnected from the ventilator, and an OHD delivery device normally used for tracheostomies (Fisher & Paykel, Optiflow+®) will be connected to the pneumotachograph.
The OHD flow rate will be set to 50 L/min.
A Monnal T60 ventilator (Air Liquide Healthcare) will be used for OHD administration.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Respiratory work during the weaning test, defined as the energy expended to inhale and exhale a respiratory gas, measured in joules per liter per minute.
Ramy czasowe: 190 min
|
190 min
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Tidal Volume
Ramy czasowe: 190 min
|
190 min
|
|
Total Positive End-Expiratory Pressure
Ramy czasowe: 190 min
|
190 min
|
|
Respiratory Rate
Ramy czasowe: 190 min
|
190 min
|
|
minute ventilation
Ramy czasowe: 190 min
|
190 min
|
|
Ratio Respiratory rate/ Tidal volume
Ramy czasowe: 190 min
|
190 min
|
|
product pressure time
Ramy czasowe: 190 min
|
190 min
|
|
Occlusion pressure (or P 0.1)
Ramy czasowe: 190 min
|
190 min
|
|
Percentage of success on the weaning test (predefined criteria)
Ramy czasowe: 190 min
|
190 min
|
Inne miary wyników
Miara wyniku |
Ramy czasowe |
|---|---|
|
Percentage of patients extubated following the series of weaning trials
Ramy czasowe: 190 min
|
190 min
|
|
Percentage of reintubations within 48 hours after extubation
Ramy czasowe: 52 hours
|
52 hours
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
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
Inne numery identyfikacyjne badania
- 38RC25.0307
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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