Back to resultsHFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High flow nasal cannula (HFNC)
Noninvasive ventilation (NIV)
Sponsored by
About this trial
This is an interventional supportive care trial for Pneumonia
Eligibility Criteria
Inclusion Criteria: Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure. The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes. Exclusion criteria: Patients requiring emergency intubation, Recent esophageal, facial, or cranial trauma or surgery, Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less), Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia, Tracheotomy or other upper airway disorders, Active upper gastrointestinal bleeding, and Inability to clear respiratory secretions .
Sites / Locations
- Doaa Magdy Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
(High flow nasal cannula (HFNC)
Noninvasive ventilation (NIV)
Arm Description
This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it.
This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it.
Outcomes
Primary Outcome Measures
The rate of intubation among participant
The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 < 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency > 40/min)
Secondary Outcome Measures
Improvement of respiratory exchanges compared to baseline
Evaluation of oxygenation (paO2 in mmHg )and hypercapnea (Pa Co2 in mmHg )using arterial blood gas )
Dyspnea
Borg dyspnea scale
Mortality rate
Patient died after reintubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05809089
Brief Title
HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Official Title
Early-initiated High Flow Nasal Oxygen Therapy in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).
To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.
Detailed Description
Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(High flow nasal cannula (HFNC)
Arm Type
Active Comparator
Arm Description
This arm should have the intervention"High flow nasal cannula (HFNC)" assigned to it.
Arm Title
Noninvasive ventilation (NIV)
Arm Type
Active Comparator
Arm Description
This arm should have the intervention "Noninvasive ventilation (NIV)" assigned to it.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula (HFNC)
Intervention Description
High-flow nasal cannula device was utilized. Humidifier temperature was set at 37°C via large-bore bi-nasal prongs, and inspired oxygen (FiO2) was adjusted to maintain oxygen saturation by pulse oximetry (SpO2) ≥ 90%.The flow was initially set at 10 L/min and titrated upward in 5 L/min steps until patients experienced discomfort.
Patient will be evaluated every 8 hours and discontinued the device for eating, drinking and coughing up secretion and returned back to the device for 72 hours.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation (NIV)
Intervention Description
Patients initiated NIV; Inspiratory positive airway pressure (IPAP) was initiated at 10-12 cmH2O, and expiratory positive airway pressure (EPAP) started at 4-5 cmH2O. FIO2 was adjusted to maintain SpO2 ≥ 90%. The same protocol as done in HFNC, patient will be evaluated every 8 hours and discontinued the device and returned back to the device for re- evaluation within 72 hours
Primary Outcome Measure Information:
Title
The rate of intubation among participant
Description
The criteria for immediate intubation were: cardiac arrest or obvious hemodynamic instability, refractory hypoxemia (PaO2 < 50mmHg with sufficient oxygen therapy), significant hypercapnia with pH ≤ 7.20, loss of consciousness or gasping for air, psychomotor agitation, or severe dyspnea (respiratory frequency > 40/min)
Time Frame
within 72 hours after admission
Secondary Outcome Measure Information:
Title
Improvement of respiratory exchanges compared to baseline
Description
Evaluation of oxygenation (paO2 in mmHg )and hypercapnea (Pa Co2 in mmHg )using arterial blood gas )
Time Frame
hospital admission until the achievement of clinical stability (72 hours)
Title
Dyspnea
Description
Borg dyspnea scale
Time Frame
hospital admission until the achievement of clinical stability (72 hours)
Title
Mortality rate
Description
Patient died after reintubation
Time Frame
at 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pneumonia adults patients (age>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.
Exclusion criteria:
Patients requiring emergency intubation,
Recent esophageal, facial, or cranial trauma or surgery,
Severely decreased consciousness (Glasgow coma scale [GCS] of 11 or less),
Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
Tracheotomy or other upper airway disorders,
Active upper gastrointestinal bleeding, and
Inability to clear respiratory secretions .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed metwaly, dectorate
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doaa Magdy Eid
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure
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