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The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HFNC flow
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemia focused on measuring High flow nasal cannula, Hypoxemia, Flow setting

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Oxygenation on hypoxemia patients

Lung expansion on healthy volunteer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

SpO2/FIO2 increment for hypoxemic patients
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
RR change for hypoxemic patients
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

comfort scores
comfort will be self-evaluation using a visual analog scale with measured score of 0 is the worst and 10 is the best

Full Information

First Posted
November 8, 2018
Last Updated
April 21, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03738345
Brief Title
The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Official Title
The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 26, 2018 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

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) 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
High flow nasal cannula, Hypoxemia, Flow setting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant will be masked by the flow setting
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygenation on hypoxemia patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Lung expansion on healthy volunteer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HFNC flow
Intervention Description
HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers
Primary Outcome Measure Information:
Title
SpO2/FIO2 increment for hypoxemic patients
Description
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
Time Frame
30 minutes
Title
RR change for hypoxemic patients
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
comfort scores
Description
comfort will be self-evaluation using a visual analog scale with measured score of 0 is the worst and 10 is the best
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Li, PhD
Organizational Affiliation
Rush University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
5 years following publication
IPD Sharing Access Criteria
contacting the corresponding author with clear description on the use of the data
Citations:
PubMed Identifier
28089816
Citation
Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.
Results Reference
result
PubMed Identifier
28104830
Citation
Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.
Results Reference
result
PubMed Identifier
28762180
Citation
Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
Results Reference
result
PubMed Identifier
27997805
Citation
Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
Results Reference
result
PubMed Identifier
28857852
Citation
Delorme M, Bouchard PA, Simon M, Simard S, Lellouche F. Effects of High-Flow Nasal Cannula on the Work of Breathing in Patients Recovering From Acute Respiratory Failure. Crit Care Med. 2017 Dec;45(12):1981-1988. doi: 10.1097/CCM.0000000000002693.
Results Reference
result
PubMed Identifier
34837553
Citation
Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.
Results Reference
derived

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The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

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