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

Acute Respiratory Failure Clinical Trial

— HPEEP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05467332
• Other study ID #: HPEEP
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Airway Disease
• Critical Illness
• Critically Ill
• Diaphragm Disease
• High Flow Nasal Cannula
• Positive End Expiratory Pressure
• Respiratory Insufficiency

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