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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755425
• Other study ID #: 139/05-05-2022
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2023
• Source: Evangelismos Hospital
• Contact: IOANNA SIGALA, PhD
• Phone: +302132041712
• Email: giannasig[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• CPAP
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
• HFNO
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

Locations

Country	Name	City	State
Greece	Evaggelismos Hospital	Athens	Attica
Greece	University General Hospital of Larissa	Larissa	Thesaly

Sponsors (2)

Lead Sponsor	Collaborator
Evangelismos Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days free from ventilatory support	days without support with either mechanical ventilation, HFNO, CPAP	28 days
Secondary	treatment failure defined	no of patients that needed intubation and invasive mechanical ventilation or died	28 days
Secondary	intubation rate		28 days
Secondary	hospital mortality		28 days
Secondary	days under non-invasive respiratory support	days without support with HFNO or CPAP	28 days
Secondary	hospital length of stay		28 days
Secondary	Partial pressure of oxygen PaO2 change at 2h, 12h and 24h		28 days