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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05467332
Other study ID # HPEEP
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2023
Est. completion date December 2023

Study information

Verified date January 2023
Source Azienda Sanitaria-Universitaria Integrata di Udine
Contact Cristian Deana, MD
Phone +390432552410
Email cristian.deana@asufc.sanita.fvg.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
HIGH FLOW NASAL OXYGEN
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.

Locations

Country Name City State
Italy Cristian Deana Udine

Sponsors (1)

Lead Sponsor Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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