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

Sponsor

Evangelismos Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05755425

Collaborator

University of Thessaly (Other)

100

Enrollment

Locations

23.2

Anticipated Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Respiratory Failure	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 22, 2022

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

days free from ventilatory support [28 days]
days without support with either mechanical ventilation, HFNO, CPAP

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evaggelismos Hospital	Athens	Attica	Greece	10676
2	University General Hospital of Larissa	Larissa	Thesaly	Greece	41110

Sponsors and Collaborators

Evangelismos Hospital
University of Thessaly

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IOANNA SIGALA, Pulmonologist-Intensivist, Evangelismos Hospital

ClinicalTrials.gov Identifier:

NCT05755425

Other Study ID Numbers:

139/05-05-2022

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IOANNA SIGALA, Pulmonologist-Intensivist, Evangelismos Hospital

CPAP

HFNO

Additional relevant MeSH terms:

Pneumonia

Respiratory Insufficiency

Study Results

No Results Posted as of Mar 6, 2023