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The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HFNC
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Failure focused on measuring high flow nasal cannula, oxygenation, ventilation, conventional oxygen therapy, Arterial Blood Gasses

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Minimal age 18 The patient had invasive blood pressure monitoring via an arterial line in situ The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention Exclusion Criteria: Shortness of breath Patients regularly using O2 at home No patient consent for participation

Sites / Locations

  • Hadassah medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all patients

Arm Description

Outcomes

Primary Outcome Measures

The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure
Change in PaO2 in mmHg(Partial pressure of oxygen in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
The effect of changing flow rates generated by HFNC on ventilation parameters of 28 patients with mild respiratory failure
Change in PaCO2 in mmHg(Partial pressure of carbon dioxide in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
January 23, 2023
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05708287
Brief Title
The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure
Official Title
The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High flow nasal cannula (HFNC) oxygen therapy is increasingly used for hypoxemic respiratory failure and is proving useful in avoiding or delaying intubation and mechanical ventilation. However, basic information regarding the physiologic effects of this method is missing. In this study, the effects of oxygen delivery by HFNC on oxygenation, ventilation and cardiovascular vital signs in patients with mild hypoxemic respiratory failure were evaluated.
Detailed Description
Oxygen (O2) therapy delivered by means of High Flow Nasal Cannula (HFNC) is being increasingly used. This device, capable of delivering high flow, oxygen enriched gas, has been shown to reduce intubation rates in patients with hypoxemic respiratory failure. The primary components of HFNC are "nasal prongs" (or cannulae) that are inserted into the nostrils, a device which provides a warmed and humidified air / oxygen mixture and regulators that control oxygen concentration, temperature and total gas flow. Commercially available systems can deliver up to 40 - 60 liters per minute (LPM) of oxygen flow. This method of non-invasive oxygen delivery has several presumed important working principals. Firstly, the high flow rate may meet the patient's own inspiratory flow rate. This enables accurate delivery of a high fractional inspired concentration of oxygen (FiO2). Second, the high gas flow might also produce a certain degree of Continuous Positive Airway Pressure (CPAP). In addition, the heated and humidified gas might also wash out/reduce the physiological airway dead space of the patient. Furthermore, HFNC is more comfortable and might be better tolerated than other Non-Invasive Ventilation (NIV) devices, such as Bi-level positive airway pressure (BiPAP). This, in turn, can prolong the time the patient is comfortably connected to the HFNC device. Information regarding the basic physiologic influence of HFNC on oxygenation, ventilation and vital signs is missing in the literature. Patients with mild respiratory failure provide an opportunity to examine this topic. On one hand, these patients suffer from respiratory failure manifested by hypoxemia, on the other hand the respiratory failure is mild to the extent that removal of the conventional oxygen therapy (COT) will not lead to immediate respiratory collapse. This prospective study evaluates the physiologic effects of HFNC in 28 patients with mild respiratory failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
high flow nasal cannula, oxygenation, ventilation, conventional oxygen therapy, Arterial Blood Gasses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
The patients with mild hypoxemia, defined as the need for conventional oxygen therapy (COT) using nasal cannula at 4-5 liters per minute (LPM) to maintain O2 Saturation >90%, were commenced on HFNC therapy
Primary Outcome Measure Information:
Title
The effect of changing flow rates generated by HFNC on oxygenation parameters of 28 patients with mild respiratory failure
Description
Change in PaO2 in mmHg(Partial pressure of oxygen in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
Time Frame
60 minutes
Title
The effect of changing flow rates generated by HFNC on ventilation parameters of 28 patients with mild respiratory failure
Description
Change in PaCO2 in mmHg(Partial pressure of carbon dioxide in arterial blood) from baseline on nasal cannula and after giving gradually increasing flow rates to 60 Liters Per Minute on HFNC, at constant FiO2 of 40%.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimal age 18 The patient had invasive blood pressure monitoring via an arterial line in situ The patient had a mild respiratory failure manifested by the need for oxygen support via nasal prongs in order to maintain oxygen saturation (SpO2) above 90% for at least one hour prior to the start of the intervention Exclusion Criteria: Shortness of breath Patients regularly using O2 at home No patient consent for participation
Facility Information:
Facility Name
Hadassah medical center
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

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The Physiologic Effect of the Flow Generated by High Flow Nasal Cannula in Mild Respiratory Failure

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