- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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.
|
|
Jiný: 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.
|
|
Jiný: 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.
|
|
Jiný: 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.
|
|
Jiný: 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.
|
|
Jiný: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
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.
Časové okno: 190 min
|
190 min
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Tidal Volume
Časové okno: 190 min
|
190 min
|
|
Total Positive End-Expiratory Pressure
Časové okno: 190 min
|
190 min
|
|
Respiratory Rate
Časové okno: 190 min
|
190 min
|
|
minute ventilation
Časové okno: 190 min
|
190 min
|
|
Ratio Respiratory rate/ Tidal volume
Časové okno: 190 min
|
190 min
|
|
product pressure time
Časové okno: 190 min
|
190 min
|
|
Occlusion pressure (or P 0.1)
Časové okno: 190 min
|
190 min
|
|
Percentage of success on the weaning test (predefined criteria)
Časové okno: 190 min
|
190 min
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Percentage of patients extubated following the series of weaning trials
Časové okno: 190 min
|
190 min
|
|
Percentage of reintubations within 48 hours after extubation
Časové okno: 52 hours
|
52 hours
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 38RC25.0307
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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