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High Flow During Weaning From Mechanical Ventilation (FLOWEAN)

Primary Purpose

Acute Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow Nasal Air
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Failure focused on measuring Dyspnea, Weaning, Mechanical ventilation, High flow nasal air

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical ICU R3S, Pitié-Salpétriêre HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

installation of the high-flow humidified nasal oxygen therapy device and variation of the inspiratory flow rate (0 L/min, 30 L/min, 50 L/min and 70 L/min) then performance of the weaning test. of the weaning test. During each step of the protocol (= each variation of the inspiratory flow), the intensity of the dyspnea will be collected, the esophageal pressure will be measured, the respiratory control will be measured, the EMG of the respiratory muscles will be measured and the comfort will be measured. Each step lasts about 15 minutes with 5 minutes of wash-out before the next step. Once the 4 conditions are tested, the weaning test is performed (without wash-out), for a duration of one hour. The whole test lasts 2h15.

Outcomes

Primary Outcome Measures

intensity of dyspnea by Mechanical ventilation Respiratory Distress Observational Scale (IC-RDOS).
Scale of 1 to 10 with 10 corresponding to significant dyspnea

Secondary Outcome Measures

inspiratory effort
Amplitude of the esophagus pressure
respiratory drive
inspiratory occlusion pressure (P0.1)
respiratory muscles activity
electromyogram of the respiratory muscles
patient comfort
Visual analogic scale. Scale of 1 to 10 with 10 corresponding to minimal comfort

Full Information

First Posted
September 26, 2022
Last Updated
February 20, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05577221
Brief Title
High Flow During Weaning From Mechanical Ventilation
Acronym
FLOWEAN
Official Title
Effect of High Flow Nasal Air on Dyspnea During Weaning From Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
February 17, 2024 (Anticipated)
Study Completion Date
February 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Dyspnea, Weaning, Mechanical ventilation, High flow nasal air

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
installation of the high-flow humidified nasal oxygen therapy device and variation of the inspiratory flow rate (0 L/min, 30 L/min, 50 L/min and 70 L/min) then performance of the weaning test. of the weaning test. During each step of the protocol (= each variation of the inspiratory flow), the intensity of the dyspnea will be collected, the esophageal pressure will be measured, the respiratory control will be measured, the EMG of the respiratory muscles will be measured and the comfort will be measured. Each step lasts about 15 minutes with 5 minutes of wash-out before the next step. Once the 4 conditions are tested, the weaning test is performed (without wash-out), for a duration of one hour. The whole test lasts 2h15.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Air
Other Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
Administration of air at high flow by using a high flow nasal oxygenation (FiO2 21%) device
Primary Outcome Measure Information:
Title
intensity of dyspnea by Mechanical ventilation Respiratory Distress Observational Scale (IC-RDOS).
Description
Scale of 1 to 10 with 10 corresponding to significant dyspnea
Time Frame
at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Secondary Outcome Measure Information:
Title
inspiratory effort
Description
Amplitude of the esophagus pressure
Time Frame
at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Title
respiratory drive
Description
inspiratory occlusion pressure (P0.1)
Time Frame
at inclusion, compare to 15, 35, 55, 75, 105 and 135 min
Title
respiratory muscles activity
Description
electromyogram of the respiratory muscles
Time Frame
at 15 min to inclusion, compare to, 35, 55, 75, 105 and 135 min
Title
patient comfort
Description
Visual analogic scale. Scale of 1 to 10 with 10 corresponding to minimal comfort
Time Frame
at inclusion, compare to 15, 35, 55, 75, 105 and 135 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Dres, MD PhD
Phone
+ 33 1 42 16 78 09
Email
Martin.dres@aphp.fr
Facility Information:
Facility Name
Medical ICU R3S, Pitié-Salpétriêre Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Dres, MD PhD
Phone
+ 33 1 42 16 78 09
Email
Martin.dres@aphp.fr

12. IPD Sharing Statement

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High Flow During Weaning From Mechanical Ventilation

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