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

NCT05467332 | Unknown

• 1 other identifier: HPEEP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

intensive care unit, critically ill patient, high flow nasal cannula, PEEP, respiratory failure, non invasive ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HFNC-EADI

  3 HOURS

Study Arms (1)

CRITICALLY ILL PATIENTS

CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED.

Device: HIGH FLOW NASAL OXYGEN

Interventions

HIGH FLOW NASAL OXYGEN DEVICE

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.

Also known as: AIRVO2, FISHER&PAYKEL

CRITICALLY ILL PATIENTS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CRITICALLY ILL PATIENTS REQUIRING INVASIVE MECHANICAL VENTILATION FOR AT LEAST 72 HOURS AND READY FOR EXTUBATION.

You may qualify if:

• age 18-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

Cristian Deana

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Cristian Deana, MD

  Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristian Deana, MD

CONTACT

+390432552410; cristian.deana@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Anesthesiologist and Critical Care Physician

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: April 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)