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Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC

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: NCT04471220
Recruitment Status : Completed
First Posted : July 15, 2020
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
National Hospital Organization Minami Kyoto Hospital

Brief Summary:
The purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2. FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min

Condition or disease Intervention/treatment Phase
High-flow Nasal Cannula Exercise Capacity Respiratory Failure Device: High-flow nasal cannula Not Applicable

Detailed Description:
In the pervious study, the investigators demonstrated that 4 weeks of training using both high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with training using a 6 L/min nasal cannula. However, it was unclear whether the effects of pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic effect. It is also unknown whether there are differences in the effects of pulmonary rehabilitation under HFNC for each underlying disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : September 29, 2022
Actual Study Completion Date : September 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Low FIO2 and low flow rate under HFNC
In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 10 L/min).
Device: High-flow nasal cannula
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Active Comparator: Low FIO2 and high flow rate under HFNC
In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min).
Device: High-flow nasal cannula
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Active Comparator: High FIO2 and low flow rate under HFNC
In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min).
Device: High-flow nasal cannula
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.

Active Comparator: High FIO2 and high flow rate under HFNC
In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min).
Device: High-flow nasal cannula
The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.




Primary Outcome Measures :
  1. Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate") [ Time Frame: through study completion, an average of 2 weeks ]

Secondary Outcome Measures :
  1. Difference in 6MWD between four conditions [ Time Frame: through study completion, an average of 2 weeks ]
  2. Difference in SpO2 value during 6MWT between four conditions [ Time Frame: through study completion, an average of 2 weeks ]
  3. Difference in Pulse rate value during 6MWT between four conditions [ Time Frame: through study completion, an average of 2 weeks ]
  4. Difference in Dyspnea during 6MWT between four conditions [ Time Frame: through study completion, an average of 2 weeks ]
  5. Difference in lower limb fatigue during 6MWT between four conditions [ Time Frame: through study completion, an average of 2 weeks ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2 0.21 and a flow rate of 10L/min)
  • Subjects who have been clinically stable for the last 2 weeks
  • Subjects with written informed consent to participate in this study

Exclusion Criteria:

  • Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure
  • Subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks
  • Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis obliterans or spinal disease

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): NCT04471220


Locations
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Japan
National Hospital Organization Minami Kyoto Hospital
Joyo, Kyoto, Japan, 610-0113
Sponsors and Collaborators
National Hospital Organization Minami Kyoto Hospital
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Responsible Party: National Hospital Organization Minami Kyoto Hospital
ClinicalTrials.gov Identifier: NCT04471220    
Other Study ID Numbers: 2019-23
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

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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 National Hospital Organization Minami Kyoto Hospital:
HFNC
6MWD
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases