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

Recruiting

• Conditions: Pneumonia; Respiratory Failure
• Interventions: Device: CPAP; Device: HFNO

• Registration Number: NCT05755425
• Lead Sponsor: Evangelismos Hospital

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.

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 Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2023-02-11
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06
• Primary Completion: 2023-12-20
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPAP	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
HFNO	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

Primary Outcome Measures

Name	Time	Method
days free from ventilatory support	28 days	days without support with either mechanical ventilation, HFNO, CPAP

Secondary Outcome Measures

Name	Time	Method
days under non-invasive respiratory support	28 days	days without support with HFNO or CPAP
treatment failure defined	28 days	no of patients that needed intubation and invasive mechanical ventilation or died
hospital length of stay	28 days
intubation rate	28 days
hospital mortality	28 days
Partial pressure of oxygen PaO2 change at 2h, 12h and 24h	28 days

Trial Locations

Locations (2)

Evaggelismos Hospital; 🇬🇷 Athens, Attica, Greece

University General Hospital of Larissa; 🇬🇷 Larissa, Thesaly, Greece