Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.

Study Overview
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Brief Summary
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High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation. It acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients. However to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients. The primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.

Official Title
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Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.

Conditions
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Acute Respiratory Failure, High Flow Nasal Cannula, Critically Ill, Airway Disease, Positive End Expiratory Pressure, Diaphragm Disease

Intervention / Treatment
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* Device: HIGH FLOW NASAL OXYGEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRITICALLY ILL PATIENTS AFTER MECHANICAL VENTILATION LASTED AT LEAST 72 HOURS age 18-80 years Exclusion Criteria: COPD stage >1 according to GOLD classification end stage organ disease (liver, kidney, heart, lung) neuromuscular disease neoplasm previous tracheostomy obesity with BMI > 35 Kg/m2 non collaborative patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRITICALLY ILL PATIENTS<br>CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED. | Device: HIGH FLOW NASAL OXYGEN<br>* BEFORE EXTUBATION, AN AIRWAY EXCHANGE CATHETER (AEC) WILL BE PUT INTO THE PATIENTS' TRACHEA AND IT WILL REMAIN IN SITE AFTER EXTUBATION. THROUGH AN AEC CONNECTED TO A PRESSURE MONITOR, IT WILL BE RECORDED TRACHEAL PRESSURE DURING SPONTANEOUSLY BREATHING PATIENT AT DIFFERENT FLOW RATES OF HFNC THAT WILL BE APPLIED JUST AFTER EXTUBATION. MEANWHILE, VITAL PARAMETERS RECORDED WITH A MULTIPARAMETRIC MONITOR WILL BE RECORDED. FINALLY, MONITORING OF ELECTRICAL ACTIVITY OF DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE TO EVALUATE IT AT DIFFERENT FLOW RATES.<br>* Other names: AIRVO2, FISHER&PAYKEL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HFNC-PEEP | THE LEVEL OF POSITIVE AIRWAY PRESSURE GENERATED BY DIFFERENT FLOW RATES OX OXYGEN WILL BE RECORDED. FLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN. | 3 HOURS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HFNC-EADI | ELECTRICAL ACTIVITY OF THE DIAPHRAGM WILL BE RECORDED THROUGH A DEDICATED NASOGASTRIC TUBE DURING ALL THE PROCESS. FLOW RATE STARTS AT 10 L/MIN AND IT WILL BE INCREASED A 10 L/MIN STEP EVERY 30 MINUTES UNTIL 60 L/MIN. | 3 HOURS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, critically ill patient, high flow nasal cannula, PEEP, respiratory failure, non invasive ventilation