Acute Respiratory FailureHPEEPNCT05467332
Tracheal Positive Pressure During High Flow Nasal Oxygen Administration in Critically Ill Patients: a Physiologic Study.
An observational study of Acute Respiratory Failure and High Flow Nasal Cannula, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Failure, High Flow Nasal Cannula, Critically Ill
- What is being tested?
- HIGH FLOW NASAL OXYGEN
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CRITICALLY ILL PATIENTS REQUIRING INVASIVE MECHANICAL VENTILATION FOR AT LEAST 72 HOURS AND READY FOR EXTUBATION.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.
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
- Being tested
- HIGH FLOW NASAL OXYGEN
- Keywords
- intensive care unit, critically ill patient, high flow nasal cannula, PEEP, respiratory failure, non invasive ventilation
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIGH FLOW NASAL OXYGENDevice
Also called AIRVO2, FISHER&PAYKEL
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.
| Study group | Role | What they receive |
|---|---|---|
| CRITICALLY ILL PATIENTS | CRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED. Receives: Device: HIGH FLOW NASAL OXYGEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 HOURS
Secondary outcomes (1)
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.
Measured: 3 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study startApr 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristian Deana, Azienda Sanitaria-Universitaria Integrata di Udine
- Investigators
- Cristian Deana, MD, Principal investigator, Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467332
- Sponsor's protocol ID
- HPEEP
- Acronym
- HPEEP
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Measurement of Positive Tracheal Pressure Generated by High Flow Nasal Oxygen Administration in Critically Ill Patients After Extubation: a Physiologic Study.
- ClinicalTrials.gov ID
- NCT05467332
- Acronym / sponsor ID
- HPEEP / HPEEP
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRITICALLY ILL PATIENTS | – | Device: HIGH FLOW NASAL OXYGENCRITICALLY ILL PATIENTS AFTER INVASIVE MECHANICAL VENTILATION READY TO BE EXTUBATED. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CRITICALLY ILL PATIENTS REQUIRING INVASIVE MECHANICAL VENTILATION FOR AT LEAST 72 HOURS AND READY FOR EXTUBATION.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- COPD stage >1 according to GOLD classification
- end stage organ disease (liver, kidney, heart, lung)
- neuromuscular disease
- neoplasm
- previous tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIGH FLOW NASAL OXYGENAlso: AIRVO2, FISHER&PAYKELBEFORE 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. | Device | CRITICALLY ILL PATIENTS |
Primary outcome
HFNC-PEEP
Time frame: 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.
1 secondary outcome
HFNC-EADI
Time frame: 3 HOURS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Deana, MD principal investigator
Health Integrated Agency of Friuli Centrale, via Pozzuolo 330, 33100 Udine, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and High Flow Nasal Cannula, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Deana, MD (+390432552410, cristian.deana@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFNC-PEEP (time frame: 3 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.