Spontaneous Breathing Trial in ICU
Conditions
Brief summary
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).
Interventions
DEVICET piece
The endotracheal tube will be disconnected from the ventilator, and a T-piece (Teleflex, Trach-Vent +®) with oxygen delivery
DEVICEPSV
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.
DEVICEHFO
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.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 190 min |
Secondary
| Measure | Time frame |
|---|---|
| Tidal Volume | 190 min |
| Total Positive End-Expiratory Pressure | 190 min |
| Respiratory Rate | 190 min |
| minute ventilation | 190 min |
| Ratio Respiratory rate/ Tidal volume | 190 min |
| product pressure time | 190 min |
| Occlusion pressure (or P 0.1) | 190 min |
| Percentage of success on the weaning test (predefined criteria) | 190 min |
Outcome results
None listed