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Trial record 1 of 1 for:    NCT03738345
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The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03738345
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

Condition or disease Intervention/treatment Phase
Hypoxemia Other: HFNC flow Not Applicable

Detailed Description:
High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely, from 20-40 LPM in COPD patients and 30-60 LPM in hypoxemic patients. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The participant will be masked by the flow setting
Primary Purpose: Treatment
Official Title: The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Actual Study Start Date : December 26, 2018
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : March 30, 2021

Arm Intervention/treatment
Experimental: Oxygenation on hypoxemia patients
Adult patients with hypoxemia will be recruited, their own breathing profiles (inspiratory flow, respiratory rates and tidal volume) will be measured. Then patients will be placed on high flow nasal cannula (HFNC), HFNC flow will be titrated based on the hospital's policy or protocol and patient's comfort, patient's clinical effects on oxygenation will be monitored and recorded during the titration process.
Other: HFNC flow
HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers

Experimental: Lung expansion on healthy volunteer
Adult healthy volunteers will be recruited, their own breathing profiles (inspiratory flow, respiratory rates and tidal volume) will be measured. Then they will be placed on HFNC, HFNC flow will be increased sequentially by research protocol and their comfort, subjects' lung expansion effects in different flow will be quantified by Electrical impedance tomography (EIT), a noninvasive assessment tool. Their comfort will also be assessed using a visual scale.
Other: HFNC flow
HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers




Primary Outcome Measures :
  1. SpO2/FIO2 increment for hypoxemic patients [ Time Frame: 30 minutes ]
    SpO2/FIO2 at the optimal/maximum /tolerable/ HFNC flow setting compared to the SpO2/FIO2 at HFNC flow matching patient's inspiratory flow or 30 L/min for hypoxemic patients

  2. RR change for hypoxemic patients [ Time Frame: 30 minutes ]
    Respiratory rates at the optimal/maximum /tolerable/ HFNC flow setting compared to the SpO2/FIO2 at HFNC flow matching patient's inspiratory flow or 30 L/min for hypoxemic patients


Secondary Outcome Measures :
  1. comfort scores [ Time Frame: 30 minutes ]
    comfort will be self-evaluation using a visual analog scale with measured score of 0 is the worst and 10 is the best



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adult patients (Age > 18yrs and < 90yrs) who need nasal cannula oxygen flow ≥ 5 L/min to maintain SpO2 at 90-97%.

Exclusion Criteria (Common): - Unable to use resuscitation mask, such as facial trauma, claustrophobia

  • Inability to verbally communicate;
  • Pregnant
  • Inability to breathe via nose, such as nasosinusitis, stuffy nose or nasal obstruction, etc.
  • Ordered SpO2 goal is above 97%
  • FIO2 needs ≤ 0.4
  • Using inhaled pulmonary vasodilator via HFNC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738345


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Jie Li, PhD Rush University
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03738345    
Other Study ID Numbers: HFNC-Flow-003
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data after deidentification that underlie the reports reported in this article can be obtained by contacting the corresponding author. Data will be available immediately following publication and ending in 5 years.
Supporting Materials: Study Protocol
Time Frame: 5 years following publication
Access Criteria: contacting the corresponding author with clear description on the use of the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
High flow nasal cannula
Hypoxemia
Flow setting
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory