Respiratory InsufficiencyNCT03534960
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
A study testing High Flow Nasal Oxygen Therapy and Nasal CPAP in people with Respiratory Insufficiency, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- High Flow Nasal Oxygen Therapy and Nasal CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2018to Dec 2018
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ranges from 1 to 18 years
- Hypercapnic respiratory failure:
- PaO2<60mmHg and PaCO2 >50 mmHg
- Candidate for non-invasive respiratory support as a result of:
- an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
- an intention to extubate the patient being managed with intubated respiratory support to non-invasive support
Who cannot join
- Participation in a concurrent study that prohibits the use of HHFNC
- Active air leak syndrome
- Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
- Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
- PaCO2<50mmHg
Trial locations and contacts
1 site in 1 country.
xingyu tong contact
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Guangyu Chen, PhD, +86-02125076143, xinhuacru@163.com
About this study
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.
Read the detailed description
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure
- Conditions
- Respiratory Insufficiency
- Being tested
- High Flow Nasal Oxygen Therapy, Nasal CPAP
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Oxygen TherapyDevice
Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
Nasal CPAPDevice
Standard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Oxygen Therapy | Other | Patients are randomized to the high flow nasal oxygen therapy group Receives: Device: High Flow Nasal Oxygen Therapy |
| Nasal CPAP | Other | Patients are randomized to the nasal continuous positive airway pressure treatment group Receives: Device: Nasal CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients in each group who require endotracheal intubation w
Measured: 24 hours
Secondary outcomes (1)
mechanical ventilation-free to day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start13 Jan 2018
- Primary completion12 Nov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534960
- Sponsor's protocol ID
- XH-17-007
- Status last verified
- May 2018
- First submitted
- 23 Jul 2017
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
- ClinicalTrials.gov ID
- NCT03534960
- Acronym / sponsor ID
- XH-17-007
- Conditions
- Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Jan 2018 (actual)
- Primary completion
- 12 Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 May 2018 (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.
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.
Detailed description
Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Oxygen Therapy | Other | Device: High Flow Nasal Oxygen TherapyPatients are randomized to the high flow nasal oxygen therapy group |
| Nasal CPAP | Other | Device: Nasal CPAPPatients are randomized to the nasal continuous positive airway pressure treatment group |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age ranges from 1 to 18 years
- Hypercapnic respiratory failure:
- PaO2<60mmHg and PaCO2 >50 mmHg
- Candidate for non-invasive respiratory support as a result of:
Key exclusion criteria (5 listed)
- Participation in a concurrent study that prohibits the use of HHFNC
- Active air leak syndrome
- Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
- Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
- PaCO2<50mmHg
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 |
|---|---|---|
| High Flow Nasal Oxygen TherapyNasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas | Device | High Flow Nasal Oxygen Therapy |
| Nasal CPAPStandard nasal CPAP via "bubble" or ventilator support at levels of 4-8 cm H2O | Device | Nasal CPAP |
Primary outcome
the number of patients in each group who require endotracheal intubation w
Time frame: 24 hours
1 secondary outcome
mechanical ventilation-free to day 28
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
xingyu tong contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Oxygen Therapy and Nasal CPAP in people with Respiratory Insufficiency, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bin he (021-25077828, hebinicu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients in each group who require endotracheal intubation w (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2018.