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Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia

Primary Purpose

Hypoxia, Oxygen Therapy, High Flow Nasal Cannula

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HFNC followed by conventional nasal cannula
Conventional nasal cannula followed by HFNC
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >20 years
  • Subjective dyspnea in room air
  • SaO2< 90% in room air
  • Oxygen requirement for nasal cannula < 6 L/m

Exclusion Criteria:

  • Unstable vital signs

    • SBP <90 mmHg
    • DBP < 60 mmHg
    • Heart rate > 120 bpm
    • Respiratory rate > 30 bpm
    • Persistent dyspnea under oxygen therapy using NC
  • Severe hypoxia

    • PaO2/FiO2< 200 mmHg
  • Unable to cooperate

    • Delirium
    • Reduced cognitive function

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    HFNC first

    LFS first

    Arm Description

    Patients in "HFNC first" receive oxygen therapy using HFNC in ahead of conventional nasal cannula oxygen therapy. After 20 minutes of HFNC therapy, patients receive conventional nasal cannula oxygen therapy.

    Patients in "LFS first" receive oxygen therapy using conventional nasal cannula in ahead of HFNC therapy. After 20 minutes of conventional nasal cannula oxygen therapy, patients receive HFNC oxygen therapy.

    Outcomes

    Primary Outcome Measures

    Tidal variation
    Tidal variation using electric impedance tomography

    Secondary Outcome Measures

    Oxygen saturation
    Oxygen saturation at using pulse oxymeter
    Respiration Rate
    Subjective comfort
    Subjective comfort using questionnaire

    Full Information

    First Posted
    October 21, 2016
    Last Updated
    October 23, 2016
    Sponsor
    Asan Medical Center
    Collaborators
    Ministry of Trade, Industry & Energy, Republic of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02943863
    Brief Title
    Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
    Official Title
    Comparison of Regional Ventilation Pattern During High Flow Nasal Cannula Between Conventional Low Flow System Nasal Cannula in Patients With Mild to Moderate Hypoxia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center
    Collaborators
    Ministry of Trade, Industry & Energy, Republic of Korea

    4. Oversight

    5. Study Description

    Brief Summary
    High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients. The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown. Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxia, Oxygen Therapy, High Flow Nasal Cannula, Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HFNC first
    Arm Type
    Active Comparator
    Arm Description
    Patients in "HFNC first" receive oxygen therapy using HFNC in ahead of conventional nasal cannula oxygen therapy. After 20 minutes of HFNC therapy, patients receive conventional nasal cannula oxygen therapy.
    Arm Title
    LFS first
    Arm Type
    Active Comparator
    Arm Description
    Patients in "LFS first" receive oxygen therapy using conventional nasal cannula in ahead of HFNC therapy. After 20 minutes of conventional nasal cannula oxygen therapy, patients receive HFNC oxygen therapy.
    Intervention Type
    Device
    Intervention Name(s)
    HFNC followed by conventional nasal cannula
    Intervention Type
    Device
    Intervention Name(s)
    Conventional nasal cannula followed by HFNC
    Primary Outcome Measure Information:
    Title
    Tidal variation
    Description
    Tidal variation using electric impedance tomography
    Time Frame
    Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
    Secondary Outcome Measure Information:
    Title
    Oxygen saturation
    Description
    Oxygen saturation at using pulse oxymeter
    Time Frame
    Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
    Title
    Respiration Rate
    Time Frame
    Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
    Title
    Subjective comfort
    Description
    Subjective comfort using questionnaire
    Time Frame
    Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >20 years Subjective dyspnea in room air SaO2< 90% in room air Oxygen requirement for nasal cannula < 6 L/m Exclusion Criteria: Unstable vital signs SBP <90 mmHg DBP < 60 mmHg Heart rate > 120 bpm Respiratory rate > 30 bpm Persistent dyspnea under oxygen therapy using NC Severe hypoxia PaO2/FiO2< 200 mmHg Unable to cooperate Delirium Reduced cognitive function
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chae-Man Lim, MD
    Organizational Affiliation
    Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25742321
    Citation
    Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
    Results Reference
    background
    PubMed Identifier
    23050520
    Citation
    Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.
    Results Reference
    background
    PubMed Identifier
    25843526
    Citation
    Hsu CF, Cheng JS, Lin WC, Ko YF, Cheng KS, Lin SH, Chen CW. Electrical impedance tomography monitoring in acute respiratory distress syndrome patients with mechanical ventilation during prolonged positive end-expiratory pressure adjustments. J Formos Med Assoc. 2016 Mar;115(3):195-202. doi: 10.1016/j.jfma.2015.03.001. Epub 2015 Apr 3.
    Results Reference
    background
    PubMed Identifier
    31723854
    Citation
    Lee DH, Kim EY, Seo GJ, Suh HJ, Huh JW, Hong SB, Koh Y, Lim CM. Global and Regional Ventilation during High Flow Nasal Cannula in Patients with Hypoxia. Acute Crit Care. 2018 Feb;33(1):7-15. doi: 10.4266/acc.2017.00507. Epub 2018 Jan 22. Erratum In: Acute Crit Care. 2021 May;36(2):173.
    Results Reference
    derived

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    Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia

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