Respiration, ArtificialNCT05035355
A SBT-based Protocol-directed Program in Difficult-to-Wean Patients
A study testing a weaning protocol in people with Respiration, Artificial, run by JinyanXing at 1 site in China.
Trial summary
Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- a weaning protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age ≥ 16 years old
- MV for more than 48 hours
- intubated or tracheostomized
Who cannot join
- pregnancy
- irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy
- pre-existing decision to limit life support
- waiving of MV during treatment
- terminal stage of severe illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
Jinyan Xing, Dr., 86-0532-82919386 ext. 82919386, xingjy@qdu.edu.cn
About this study
Official title: A Spontaneous Breathing Trial-based Protocol-directed Program in Difficult-to-Wean Patients
Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.
- Conditions
- Respiration, Artificial
- Being tested
- a weaning protocol
- Keywords
- Protocol-directed weaning, Mechanical ventilation, High-flow nasal cannula, Spontaneous breathing trial
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a weaning protocolProcedure or surgery
a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)
| Study group | Role | What they receive |
|---|---|---|
| weaning protocol group | Experimental | spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula group Receives: Procedure: a weaning protocol |
| routine SBT weaning group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical ventilation days
the duration of mechanical ventilation
Measured: 60 days
Secondary outcomes (1)
re-intubated within 24 hours
re-intubated within 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JinyanXing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JinyanXing, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035355
- Sponsor's protocol ID
- QYFYWZLL26347
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Spontaneous Breathing Trial-based Protocol-directed Program in Difficult-to-Wean Patients
- ClinicalTrials.gov ID
- NCT05035355
- Acronym / sponsor ID
- QYFYWZLL26347
- Conditions
- Respiration, Artificial
- Keywords
- Protocol-directed weaning, Mechanical ventilation, High-flow nasal cannula, Spontaneous breathing trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- JinyanXingUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Sep 2021 (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.
Weaning patients from a ventilator is one of the most challenging processes in an intensive care unit. The investigators aimed to determine whether spontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula (HFNC) could be superior to routine SBT-based weaning in reducing the duration of mechanical ventilation (MV) in difficult-to-wean patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weaning protocol group | Experimental | Procedure: a weaning protocolspontaneous breathing trial (SBT)-based protocol-directed weaning combined with the high-flow nasal cannula group |
| routine SBT weaning group | No intervention | – |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 16 years old
- MV for more than 48 hours
- intubated or tracheostomized
Key exclusion criteria (5 listed)
- pregnancy
- irreversible respiratory failure caused by neurodegenerative disorders, such as Alzheimer disease, motor neuron disease, or multiple system atrophy
- pre-existing decision to limit life support
- waiving of MV during treatment
- terminal stage of severe illness
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 |
|---|---|---|
| a weaning protocola weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC) | Procedure or surgery | weaning protocol group |
Primary outcome
mechanical ventilation days
Time frame: 60 days
the duration of mechanical ventilation
1 secondary outcome
re-intubated within 24 hours
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a weaning protocol in people with Respiration, Artificial, run by JinyanXing 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 3 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 10 Sep 2021. 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 Jinyan Xing, Doctor (86-0532-82919386 ext. 82919386, xingjy@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical ventilation days (time frame: 60 days). 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 10 Sep 2021.