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Completed

NCT Number: NCT05577221

High Flow During Weaning From Mechanical Ventilation

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.

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Key information

Conditions

Acute Respiratory Failure Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical ICU R3S, Pitié-Salpétriêre Hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No esophageal probe in place
  • Extubation planned without a spontaneous breathing trial
  • Glasgow coma scale< 12
  • Patient's refusal
  • No coverage by the national health insurance
  • Patient under legal protection of justice

Treatment and study plan

High Flow Nasal Air

Device

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

Other names: High Flow Nasal Cannula

Primary outcomes

  1. The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.

    Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

    Dyspnea Numerical Rating Scale from 0 to 10

  2. The effect of high-flow humidified nasal oxygen therapy on dyspnea in orotracheally intubated patients at the time of weaning from mechanical ventilation.

    Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

    Mechanical Ventilation Respiratory Distress Observational Scale

Secondary outcomes

  1. inspiratory effort

    Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

    Amplitude of the esophagus pressure

  2. respiratory drive

    Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

    inspiratory occlusion pressure (P0.1)

  3. respiratory muscles activity

    Time frame: at 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 min

    electromyogram of the respiratory muscles

  4. patient comfort

    Time frame: at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

    Visual analogic scale. Scale of 1 to 10 with 10 corresponding to minimal comfort

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: FLOWEAN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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