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

Not yet recruiting

• Conditions: High Flow Nasal Cannula; Acute Respiratory Failure; Airway Disease; Positive End Expiratory Pressure; Diaphragm Disease; Critically Ill
• Interventions: Device: HIGH FLOW NASAL OXYGEN

• Registration Number: NCT05467332
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31
• Study Start: 2023-04
• Primary Completion: 2023-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRITICALLY ILL PATIENTS	HIGH FLOW NASAL OXYGEN	CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED.

Primary Outcome Measures

Name	Time	Method
HFNC-PEEP	3 HOURS	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.

Secondary Outcome Measures

Name	Time	Method
HFNC-EADI	3 HOURS	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.

Trial Locations

Locations (1)

Cristian Deana; 🇮🇹 Udine, Italy