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

NCT05755425 | Unknown

• 1 other identifier: 139/05-05-2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pneumonia; Respiratory Failure

Keywords

CPAP; HFNO

Outcome Measures

Primary Outcomes (1)

• days free from ventilatory support

  days without support with either mechanical ventilation, HFNO, CPAP

  28 days

Secondary Outcomes (6)

• treatment failure defined

  28 days

• intubation rate

  28 days

• hospital mortality

  28 days

• days under non-invasive respiratory support

  28 days

• hospital length of stay

  28 days

Study Arms (2)

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

CPAP DEVICE

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

CPAP

HFNO DEVICE

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

HFNO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evangelismos Hospital: lead
• University of Thessaly: collaborator

Study Sites (2)

Evaggelismos Hospital

Athens, Attica, 10676, Greece

RECRUITING

University General Hospital of Larissa

Larissa, Thesaly, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

IOANNA SIGALA, PhD

CONTACT

+302132041712; giannasig@yahoo.com

IOANNIS KALOMENIDIS, PhD

CONTACT

+302132041712; ikalom@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist-Intensivist

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: March 6, 2023
• Study Start: February 22, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 30, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

GR (2)