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
About this trial
This is an interventional treatment trial for Hypoxia
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
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
NCT ID
NCT02943863
First Posted
October 21, 2016
Last Updated
October 23, 2016
Sponsor
Asan Medical Center
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea
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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