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

NCT ID: NCT05467332

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CRITICALLY ILL PATIENTS

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

HIGH FLOW NASAL OXYGEN

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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AIRVO2, FISHER&PAYKEL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Cristian Deana

Medical Doctor, Anesthesiologist and Critical Care Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cristian Deana, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Cristian Deana

Udine, , Italy

Site Status

Countries

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Italy

Central Contacts

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Cristian Deana, MD

Role: CONTACT

+390432552410

Other Identifiers

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HPEEP

Identifier Type: -

Identifier Source: org_study_id

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