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High Flow During Weaning From Mechanical Ventilation

Effect of High Flow Nasal Air on Dyspnea During Weaning From Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05577221
Acronym
FLOWEAN
Enrollment
20
Registered
2022-10-13
Start date
2023-02-17
Completion date
2023-09-07
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

Dyspnea, Weaning, Mechanical ventilation, High flow nasal air

Brief summary

Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Pharmacological treatments are effective but their use is likely to delay separation with the ventilator. Promoting the development of non-pharmacological interventions is therefore an interesting avenue. The hypothesis is that the application of high-flow humidified nasal air in orotracheally intubated patients can decrease the work of breathing and relieve dyspnea at the time of weaning from mechanical ventilation. Patients will be exposed to stepwise increase in high flow nasal air (0 L/min, 30 L/min, 50 L/min and 70 L/min) before to undergo a 60 minutes spontaneous breathing trial. During the protocol, dyspnea, inspiratory effort, respiratory drive, respiratory muscles electromyogram (EMG) and patient's comfort will be assessed.

Detailed description

Patients equipped with an esophageal probe and deemed ready to undergo a spontaneous breathing trial will be included. During, the inclusion visit, main characteristics of the patients and ICU stay will be collected in the patient's chart: age, sex, comorbidities, date of admission to intensive care, date of intubation, severity score (SOFA), reason for admission to intensive care , weight, height, ventilation settings, P0.1, respiratory rate, SpO2, dyspnea and comfort score. Secondarily, the quality of the esophageal pressure signal will be checked. Esophageal pressure will be collected using a nasogastric tube (NutriventTM, SIDAM, Italy). Esophageal pressure will be measured continuously by the Labchart system installed on the department's dedicated computer. Third, the EMG collection device will be implemented. EMG signals will be collected by surface electrodes on the scalene and intercostal muscles and on the sides of the nose. The electrodes are connected to collection modules operating with the LabChart system. Finally, the high-flow humidified air device will be installed (AIRVO 2; Fisher and Paykel Healthcare, Auckland, New Zealand) and nasal cannulas adapted to the patient's anatomy will be positioned. The FiO2 will be fixed at 21% for the duration of the study. The flow will be set at 0 L/min at the inclusion visit. The humidified air temperature will be set to 37°C. The protocol will consist of installing the high-flow humidified nasal oxygen therapy device and varying the nasal flow (4 different conditions: 0 L/min, 30 L/min, 50 L/min and 70 L/min) then performing the spontaneous breathing trial (duration 60 minutes). During each of the steps of the protocol, a collection of the intensity of the dyspnea, a measurement of the esophageal pressure, a measurement of the respiratory drive, an EMG measurement of the respiratory muscles and a comfort assessment will be carried out.

Interventions

DEVICEHigh Flow Nasal Air

Administration of air at high flow by using a high flow nasal oxygenation (FiO2 21%) device

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Age \> 18 years old 2. orotracheal intubation 3. Decision to initiate a spontaneous breathing trial by the clinical team 4. Visual analogic scale of dyspnea \> 3/10 5. Informed consent to participate 6. Patient covered by the national health

Exclusion criteria

1. No esophageal probe in place 2. Extubation planned without a spontaneous breathing trial 3. Glasgow coma scale\< 12 4. Patient's refusal 5. No coverage by the national health insurance 6. Patient under legal protection of justice

Design outcomes

Primary

MeasureTime frameDescription
The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.at inclusion, compare to 15, 35, 55, 75, 105 and 135 minDyspnea Numerical Rating Scale from 0 to 10

Secondary

MeasureTime frameDescription
inspiratory effortat inclusion, compare to 15, 35, 55, 75, 105 and 135 minAmplitude of the esophagus pressure
respiratory driveat inclusion, compare to 15, 35, 55, 75, 105 and 135 mininspiratory occlusion pressure (P0.1)
respiratory muscles activityat 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 minelectromyogram of the respiratory muscles
patient comfortat inclusion, compare to 15, 35, 55, 75, 105 and 135 minVisual analogic scale. Scale of 1 to 10 with 10 corresponding to minimal comfort

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026