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RecruitingNCT05755425Updated Mar 6, 2023

CPAP Versus HFNO for the Treatment of Acute Hypoxemic Respiratory Failure Due to Community Acquired Pneumonia

An observational study in Pneumonia and Respiratory Failure, sponsored by Evangelismos Hospital. Recruiting at 2 sites in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Evangelismos Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Pneumonia
  • Respiratory Failure

Keywords

  • CPAP
  • HFNO
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's planned enrollment of 100 is below the median of 252 across 535 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Evangelismos Hospital is the lead sponsor of 29 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Need for immediate or imminent intubation
  • not fit for escalation of treatment: defined as intubation, mechanical ventilation and ICU support.
  • Pregnant women
  • to CPAP or HFNO
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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

    Device: HFNO

Interventions

  • DeviceCPAP

    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

  • DeviceHFNO

    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

06

What researchers measure

Primary outcomes

  1. days free from ventilatory support

    days without support with either mechanical ventilation, HFNO, CPAP

    Time frame: 28 days

Secondary outcomes

  1. treatment failure defined

    no of patients that needed intubation and invasive mechanical ventilation or died

    Time frame: 28 days

  2. intubation rate

    Time frame: 28 days

  3. hospital mortality

    Time frame: 28 days

  4. days under non-invasive respiratory support

    days without support with HFNO or CPAP

    Time frame: 28 days

  5. hospital length of stay

    Time frame: 28 days

  6. Partial pressure of oxygen PaO2 change at 2h, 12h and 24h

    Time frame: 28 days

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05755425
Lead sponsor
Evangelismos Hospital
Responsible party
IOANNA SIGALA (Pulmonologist-Intensivist, Evangelismos Hospital) — Principal investigator
First posted
Mar 6, 2023
Start date
Feb 22, 2022
Primary completion
Dec 20, 2023 (estimated)
Completion
Jan 30, 2024 (estimated)
Last update
Mar 6, 2023

Study contacts

IOANNA SIGALA, PhD
Contact
giannasig@yahoo.com
+302132041712
IOANNIS KALOMENIDIS, PhD
Contact
ikalom@med.uoa.gr
+302132041712

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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