Critically IllnessHHHFNCNCT04564859
The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC
A study testing Heated Humidified High-Flow Nasal Cannula in people with Critically Illness, run by Shin Kong Wu Ho-Su Memorial Hospital.
Trial summary
The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Critically Illness
- What is being tested?
- Heated Humidified High-Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Over 20 years of age
- the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days
Who cannot join
- Pregnancy
- Status post tracheostomy
- Neuromuscular diseases
- Signed "do not resuscitate" order
- Unplanned extubation
About this study
Official title: The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center
The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.
Read the detailed description
There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.
These review all have similar results summarized here:
Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.
However, most of these clinical trials focused on participants experiencing acute respiratory failure.
Investigators of this study want to find something difference between oh these two groups.
- Conditions
- Critically Illness
- Being tested
- Heated Humidified High-Flow Nasal Cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Humidified High-Flow Nasal CannulaDevice
Also called Noninvasive Ventilation
Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Ventilation group | Experimental | Noninvasive Ventilation group initial setting： Insp. Pressure：12 ~ 16 centimeter of water Exp. Pressure ： 4 ~ 6 centimeter of water FiO2：Keep oxygen saturation measured by pulse oximeter：> 92% By condition, gradually tap 2~3 centimeter of water inspiratory positive airway pressure Keep Tidal volume：6~10 ml/kg Receives: Device: Heated Humidified High-Flow Nasal Cannula |
| Heated Humidified High-Flow Nasal Cannula group | Active comparator | Heated Humidified High-Flow Nasal Cannula group initial setting： Flow setting: 50 L/m FiO2：Keep oxygen saturation measured by pulse oximeter > 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m Receives: Device: Heated Humidified High-Flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intubation rate
Any placement of an endotracheal tube for any indication within 72 hours of extubation, censored at the first of hospital discharge or 72 hours after extubation.
Measured: within 72 hours of extubation
Secondary outcomes (1)
Mortality rate
Mortality rate, or death rate is a measure of the number of deaths
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllnessStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Jen Catholic University
- Responsible party
- Sponsor
- Investigators
- Chen-Chun Lin, MD, Study chair, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564859
- Sponsor's protocol ID
- SKH-8302-106-NDR-05
- Acronym
- HHHFNC
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tseng CW, Chao KY, Wu HL, Lin CC, Hsu HS. Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. Sci Rep. 2023 Mar 22;13(1):4689. doi: 10.1038/s41598-023-31444-8.
PubMed 36949116
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center
- ClinicalTrials.gov ID
- NCT04564859
- Acronym / sponsor ID
- HHHFNC / SKH-8302-106-NDR-05
- Conditions
- Critically Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- Fu Jen Catholic University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Sep 2020 (actual)
- 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.
The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.
Detailed description
There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.
These review all have similar results summarized here:
Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.
However, most of these clinical trials focused on participants experiencing acute respiratory failure.
Investigators of this study want to find something difference between oh these two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Ventilation group | Experimental | Device: Heated Humidified High-Flow Nasal CannulaNoninvasive Ventilation group initial setting： Insp. Pressure：12 ~ 16 centimeter of water Exp. Pressure ： 4 ~ 6 centimeter of water FiO2：Keep oxygen saturation measured by pulse oximeter：> 92% By condition, gradually tap 2~3 centimeter of water inspiratory positive airway pressure Keep Tidal volume：6~10 ml/kg |
| Heated Humidified High-Flow Nasal Cannula group | Active comparator | Device: Heated Humidified High-Flow Nasal CannulaHeated Humidified High-Flow Nasal Cannula group initial setting： Flow setting: 50 L/m FiO2：Keep oxygen saturation measured by pulse oximeter > 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: Over 20 years of age
- the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days
Key exclusion criteria (5 listed)
- Pregnancy
- Status post tracheostomy
- Neuromuscular diseases
- Signed "do not resuscitate" order
- Unplanned extubation
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 |
|---|---|---|
| Heated Humidified High-Flow Nasal CannulaAlso: Noninvasive VentilationParticipants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices. | Device | Heated Humidified High-Flow Nasal Cannula group, Noninvasive Ventilation group |
Primary outcome
Re-intubation rate
Time frame: within 72 hours of extubation
Any placement of an endotracheal tube for any indication within 72 hours of extubation, censored at the first of hospital discharge or 72 hours after extubation.
1 secondary outcome
Mortality rate
Time frame: up to 3 months
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 Sep 2020.
- Derived from this study: PubMed 36949116Tseng CW, Chao KY, Wu HL, Lin CC, Hsu HS. Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. Sci Rep. 2023 Mar 22;13(1):4689. doi: 10.1038/s41598-023-31444-8.
Related trials for Critically Illness
Not yet recruiting
Pilot Trial of Ambient Listening for Intensive Care Unit Family Meeting Summaries
Documentation of Serious Illness Communication for Critically Ill Patients
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
RecruitingObservational study
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Cardiac Disease, Critically Ill
Not yet recruitingObservational study
HERMES: Quality and Safety of Advanced Respiratory Support During Patient Transport
Acute Respiratory Failure, Respiratory Insufficiency
Recruiting
Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver
Critical Illness, Critically Ill Patients
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.
Chen-Chun Lin, MD study chair
Shin Kong Wu Ho-Su Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Heated Humidified High-Flow Nasal Cannula in people with Critically Illness, run by Shin Kong Wu Ho-Su Memorial Hospital.
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 2 inclusion and 5 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 Sep 2020. 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?
Re-intubation rate (time frame: within 72 hours of extubation). 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 NCT04564859, which also lists 1 linked publication.
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 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.