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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Respiratory Failure
• Intervention / Treatment: Device: CPAP; Device: HFNO

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: IOANNA SIGALA, PhD; Phone Number: +302132041712; Email: giannasig@yahoo.com
• Study Contact Backup: Name: IOANNIS KALOMENIDIS, PhD; Phone Number: +302132041712; Email: ikalom@med.uoa.gr

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 10676
      • Recruiting
      • Evaggelismos Hospital
      • Contact: IOANNA SIGALA, PhD; Phone Number: +302132041712; Email: giannasig@yahoo.com
      • Contact: IOANNIS KALOMENIDIS, PhD; Phone Number: +302132041712; Email: ikalom@med.uoa.gr
  • Thesaly
    • Larissa, Thesaly, Greece, 41110
      • Recruiting
      • University General Hospital of Larissa
      • Contact: IOANNIS PANTAZOPOULOS, PhD; Phone Number: +302413501179; Email: pantazopoulosioannis@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
days free from ventilatory support	days without support with either mechanical ventilation, HFNO, CPAP	28 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Evangelismos Hospital
• Collaborators: University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: February 11, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: CPAP; HFNO
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Pneumonia
• Other Study ID Numbers: 139/05-05-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No