Effect of HFNO Therapy on Respiratory Effort After Extubation

Study Overview
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Brief Summary
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Rationale: Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is used as post-extubation respiratory support. Although HFNO seems to reduce the need for re-intubation, scepticism on its use persists as the mechanism of action in post-extubation patients remains undefined. Monitoring weaning from invasive mechanical ventilation while monitoring respiratory effort might help to determine the added value of HFNO surrounding extubation. We hypothesize that HFNO, compared to conventional oxygen therapy (COT), prevents de-recruitment of the lung and reduces respiratory effort, and so provides a physiologic clarification for the reduction in the need for reintubation. Objective: Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration. Study design: A physiologic, randomized clinical study comparing two standard of clinical care therapies. Study population: Adult patients on invasive mechanical ventilation (IMV) for >72 hours, who are scheduled for extubation. Intervention (if applicable): Before extubation, patients are randomized to receive COT (reference group) or HFNO as oxygenation regimen after extubation. Main study parameters/endpoints: The main outcome is the difference in change in lung respiratory muscle effort (mean ΔPES) at 24 hours post-extubation between the study groups. Secondary parameters are differences in changes in respiratory effort at 2 and 4 hours post-extubation, difference in change in lung aeration (mean ΔEELI), differences in tidal volume, Lung Ultrasound (LUS) score, dyspnea score, and respiratory and sputum parameters between patients undergoing different post-extubation oxygenation regimens.

Official Title
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High Flow Nasal Oxygen Therapy Re-evaluated From a Conceptual Point of View: Effect on Respiratory Effort and Lung Aeration After Extubation

Conditions
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Respiratory Failure, Post Extubation Acute Respiratory Failure Requiring Reintubation

Intervention / Treatment
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* Other: High Flow Nasal Oxygen
* Other: Conventional Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years Receiving IMV > 72 hours for any cause Successfully completing spontaneous breathing trial (SBT) as per local clinical guideline Provided written informed consent, through legal representatives on indication Exclusion Criteria: Any clinical situation preventing appropriate execution of study procedures The presence of a tracheostomy Any feature that precludes HFNO-initiation Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome with CPAP use in medical history Inability to perform adequate EIT-measurements Contra-indication for nasogastric tube or inability to perform adequate PES measurements. Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray and evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement during sniffing) Known pregnancy or current breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Flow Nasal Oxygen<br>60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celcius. | Other: High Flow Nasal Oxygen<br>* Flow 60L/minute. FiO2 according to clinical protocol. Temperature highest tolerated by patient, starting with 37 degrees Celsius.<br>* Other names: Nasal High Flow Therapy;|
| Active Comparator: Conventional Oxygen therapy<br> | Other: Conventional Oxygen Therapy<br>* Nasal Cannula, Venturi Mask or Non-rebreathing mask, according to local clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean delta Esophageal Pressure (ΔPES) | The difference between groups in change in mean ΔPES in patients 24 hours post-extubation. | At 24 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean ΔPES | The difference between groups in change in mean ΔPES after extubation | At 2 and 4 hours post-extubation | 
| delta global End-expiratory lung impedance (∆EELIglobal) | Difference between the groups in change in mean ∆EELIglobal | At 2, 4 and 24 hours after extubation | 
| Pressure-time product of Esophageal Pressure (PTPES) | The difference between the groups in mean pressure-time product (PTPES) compared to baseline. | At 2,4 and 24 hours after extubation | 
| Lung ultrasound (LUS) score | Difference between groups in LUS scores | At 2 and 24 hours after extubation. | 
| Dyspnea score | Difference in dyspnea sensation between the groups, measured with Visual Analog Scale (VAS, ranging from 0 = No dyspnea until 10 = maximum dyspnea). | At 2 and 24 hours after extubation | 
| Sputum | Difference in sputum aspect and sputum clearance between the study groups, assessed with a 5-point likert scale. | At 2 and 24 hours after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-flow oxygen, Intensive Care Unit, Extubation, Reintubation, Respiratory Effort, Aeration