PneumoniaNCT05755425
CPAP Versus HFNO for the Treatment of Acute Hypoxemic Respiratory Failure Due to Community Acquired Pneumonia
An observational study of Pneumonia and Respiratory Failure, run by Evangelismos Hospital at 2 sites in Greece.
Trial summary
the study compares two non-invasive respiratory support modalities ie CPAP and High Flow nasal cannula oxygen for the treatment of severe hypoxemic respiratory failure attributed to Community acquired Pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumonia, Respiratory Failure
- What is being tested?
- CPAP and HFNO
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesGreece
- Study dates
- 22 Feb 2022to 30 Jan 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients with community acquired pneumonia induced acute hypoxemic respiratory failure that are hospitalized in the common ward and need FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min.
Who may be able to join
- Adult patients with age >18 year old.
- Been hospitalized with community acquired pneumonia
- hospitalized in common ward (not ICU)
- Patients should have pneumonia- pulmonary infiltrates in chest-xray and hypoxemic respiratory failure.
- Patients should be unable to keep: SpO2>93% with FiO2 50%, or SpO2 95% with FiO2 50% and have evidence of respiratory distress defined as Respiratory rate -RR>35/min
Who cannot join
- Need for immediate or imminent intubation
- not fit for escalation of treatment: defined as intubation, mechanical ventilation and ICU support.
- Pregnant women
- Contraindication to CPAP or HFNO
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Evaggelismos Hospital
Athens, Attica, 10676
IOANNA SIGALA, PhD, +302132041712, giannasig@yahoo.com
IOANNIS KALOMENIDIS, PhD, +302132041712, ikalom@med.uoa.gr
- Recruiting
University General Hospital of Larissa
Larissa, Thesaly, 41110
IOANNIS PANTAZOPOULOS, PhD, +302413501179, pantazopoulosioannis@yahoo.com
About this study
Official title: CPAP Versus High Flow Nasal Cannula Oxygen for the Treatment of Patients With Community Acquired Pneumonia Induced Acute Hypoxemic Respiratory Failure in the Ward
the study compares two non-invasive respiratory support modalities ie CPAP and High Flow nasal cannula oxygen for the treatment of severe hypoxemic respiratory failure attributed to Community acquired Pneumonia.
Read the detailed description
CPAP and High Flow nasal cannula oxygen are two established modalities for non-invasive respiratory support . In COVID pandemic era both CPAP and HFNO were widely used in the ward for the treatment of COVID-19 induced acute hypoxemic respiratory failure in order to prevent progression to intubation. Head to head comparison between the two modalities mentioned for the treatment of severe hypoxemic respiratory failure is not available neither in COVID pneumonia or Community acquired pneumonia (CAP).
- Conditions
- Pneumonia, Respiratory Failure
- Being tested
- CPAP, HFNO
- Keywords
- CPAP, HFNO
- Medical subject headings
- Pneumonia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP will be delivered with a CPAP valve with venturi flow system with full-face mask. Treatment will start with CPAP set at 10cmH2O and FiO2 60% to target a SpO2 ≥90% or PO2 ≥60mmHg and then adjusted according to SpO2, respiratory distress and clinical tolerance
HFNODevice
HFNO will be applied initially at maximal settings: 100% FiO2, flow rate 60 L/min and temperature 37C . Within 1 to 2 h, the HFNO settings should be titrated based on patients respiratory rate (<25-30 per minute), SpO2 (92-96%) and comfort
| Study group | Role | What they receive |
|---|---|---|
| CPAP | When a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, full face CPAP will be applied Receives: Device: CPAP | |
| HFNO | When a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, HFNO will be applied Receives: Device: HFNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
days free from ventilatory support
days without support with either mechanical ventilation, HFNO, CPAP
Measured: 28 days
Secondary outcomes (6)
treatment failure defined
no of patients that needed intubation and invasive mechanical ventilation or died
Measured: 28 days
intubation rate
Measured: 28 days
hospital mortality
Measured: 28 days
days under non-invasive respiratory support
days without support with HFNO or CPAP
Measured: 28 days
hospital length of stay
Measured: 28 days
Partial pressure of oxygen PaO2 change at 2h, 12h and 24h
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start22 Feb 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly
- Responsible party
- Principal investigator, IOANNA SIGALA, Evangelismos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755425
- Sponsor's protocol ID
- 139/05-05-2022
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Versus High Flow Nasal Cannula Oxygen for the Treatment of Patients With Community Acquired Pneumonia Induced Acute Hypoxemic Respiratory Failure in the Ward
- ClinicalTrials.gov ID
- NCT05755425
- Acronym / sponsor ID
- 139/05-05-2022
- Conditions
- Pneumonia, Respiratory Failure
- Keywords
- CPAP, HFNO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Collaborators
- University of Thessaly
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 6 Mar 2023 (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.
the study compares two non-invasive respiratory support modalities ie CPAP and High Flow nasal cannula oxygen for the treatment of severe hypoxemic respiratory failure attributed to Community acquired Pneumonia.
Detailed description
CPAP and High Flow nasal cannula oxygen are two established modalities for non-invasive respiratory support . In COVID pandemic era both CPAP and HFNO were widely used in the ward for the treatment of COVID-19 induced acute hypoxemic respiratory failure in order to prevent progression to intubation. Head to head comparison between the two modalities mentioned for the treatment of severe hypoxemic respiratory failure is not available neither in COVID pneumonia or Community acquired pneumonia (CAP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | – | Device: CPAPWhen a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, full face CPAP will be applied |
| HFNO | – | Device: HFNOWhen a patient needs FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min, HFNO will be applied |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients with community acquired pneumonia induced acute hypoxemic respiratory failure that are hospitalized in the common ward and need FiO2 >50% to keep SpO2 >93%, or SpO2 >95% in case of persistent respiratory distress defined as RR>35/min.
Key inclusion criteria (5 listed)
- Adult patients with age >18 year old.
- Been hospitalized with community acquired pneumonia
- hospitalized in common ward (not ICU)
- Patients should have pneumonia- pulmonary infiltrates in chest-xray and hypoxemic respiratory failure.
- Patients should be unable to keep: SpO2>93% with FiO2 50%, or SpO2 95% with FiO2 50% and have evidence of respiratory distress defined as Respiratory rate -RR>35/min
Key exclusion criteria (4 listed)
- Need for immediate or imminent intubation
- not fit for escalation of treatment: defined as intubation, mechanical ventilation and ICU support.
- Pregnant women
- Contraindication to CPAP or HFNO
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 |
|---|---|---|
| CPAPCPAP will be delivered with a CPAP valve with venturi flow system with full-face mask. Treatment will start with CPAP set at 10cmH2O and FiO2 60% to target a SpO2 ≥90% or PO2 ≥60mmHg and then adjusted according to SpO2, respiratory distress and clinical tolerance | Device | CPAP |
| HFNOHFNO will be applied initially at maximal settings: 100% FiO2, flow rate 60 L/min and temperature 37C . Within 1 to 2 h, the HFNO settings should be titrated based on patients respiratory rate (<25-30 per minute), SpO2 (92-96%) and comfort | Device | HFNO |
Primary outcome
days free from ventilatory support
Time frame: 28 days
days without support with either mechanical ventilation, HFNO, CPAP
6 secondary outcomes
treatment failure defined
Time frame: 28 days
intubation rate
Time frame: 28 days
hospital mortality
Time frame: 28 days
days under non-invasive respiratory support
Time frame: 28 days
hospital length of stay
Time frame: 28 days
Partial pressure of oxygen PaO2 change at 2h, 12h and 24h
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Respiratory Failure, run by Evangelismos Hospital at 2 sites in Greece.
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 5 inclusion and 4 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 IOANNA SIGALA, PhD (+302132041712, giannasig@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days free from ventilatory support (time frame: 28 days). 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 6 Mar 2023.