HypoxiaNCT02943863
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
A study testing HFNC followed by conventional nasal cannula and Conventional nasal cannula followed by HFNC in people with Hypoxia and Oxygen Therapy, run by Asan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypoxia, Oxygen Therapy, High Flow Nasal Cannula
- What is being tested?
- HFNC followed by conventional nasal cannula and Conventional nasal cannula followed by HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >20 years
- Subjective dyspnea in room air
- SaO2< 90% in room air
- Oxygen requirement for nasal cannula < 6 L/m
Who cannot join
- Unstable vital signs
- SBP <90 mmHg
- DBP < 60 mmHg
- Heart rate > 120 bpm
- Respiratory rate > 30 bpm
- Persistent dyspnea under oxygen therapy using NC
Show all 11Show fewer
- Severe hypoxia
- PaO2/FiO2< 200 mmHg
- Unable to cooperate
- Delirium
- Reduced cognitive function
About this study
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
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.
- Conditions
- Hypoxia, Oxygen Therapy, High Flow Nasal Cannula, Ventilation
- Being tested
- HFNC followed by conventional nasal cannula, Conventional nasal cannula followed by HFNC
- Medical subject headings
- Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNC followed by conventional nasal cannulaDevice
Conventional nasal cannula followed by HFNCDevice
| Study group | Role | What they receive |
|---|---|---|
| HFNC first | Active comparator | 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. Receives: Device: HFNC followed by conventional nasal cannula |
| LFS first | Active comparator | 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. Receives: Device: Conventional nasal cannula followed by HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal variation
Tidal variation using electric impedance tomography
Measured: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Secondary outcomes (3)
Oxygen saturation
Oxygen saturation at using pulse oxymeter
Measured: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Respiration Rate
Measured: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Subjective comfort
Subjective comfort using questionnaire
Measured: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Responsible party
- Principal investigator, Chae-Man Lim, Asan Medical Center
- Investigators
- Chae-Man Lim, MD, Principal investigator, Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943863
- Sponsor's protocol ID
- OMNI
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
Publications
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.
PubMed 25742321Riera 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.
PubMed 23050520Hsu 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.
PubMed 25843526Lee 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.
PubMed 31723854
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02943863
- Acronym / sponsor ID
- OMNI
- Conditions
- Hypoxia, Oxygen Therapy, High Flow Nasal Cannula, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC first | Active comparator | Device: HFNC followed by conventional nasal cannulaPatients 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. |
| LFS first | Active comparator | Device: Conventional nasal cannula followed by HFNCPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >20 years
- Subjective dyspnea in room air
- SaO2< 90% in room air
- Oxygen requirement for nasal cannula < 6 L/m
Key exclusion criteria (11 listed)
- Unstable vital signs
- Severe hypoxia
- Unable to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNC followed by conventional nasal cannula | Device | HFNC first |
| Conventional nasal cannula followed by HFNC | Device | LFS first |
Primary outcome
Tidal variation
Time frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Tidal variation using electric impedance tomography
3 secondary outcomes
Oxygen saturation
Time frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Respiration Rate
Time frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Subjective comfort
Time frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 25742321Spoletini 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.
- Background: PubMed 23050520Riera 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.
- Background: PubMed 25843526Hsu 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.
- Derived from this study: PubMed 31723854Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chae-Man Lim, MD principal investigator
Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan
Questions about this trial
What is this clinical trial studying?
A study testing HFNC followed by conventional nasal cannula and Conventional nasal cannula followed by HFNC in people with Hypoxia and Oxygen Therapy, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal variation (time frame: Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943863, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.