Ventilator WeaningNCT01535755
A Protocol to Wean From Noninvasive Mechanical Ventilation
A study testing protocol and physician's orders in people with Ventilator Weaning, run by Duan jun at 1 site in China.
Trial summary
The investigators use a protocol to wean from noninvasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- protocol and physician's orders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- noninvasive mechanical ventilation > 24 hours.
- age >18 years
Who cannot join
- severe cerebraI，heart，hepatic and renal faiIure.
- facial or cranial trauma or surgery.
- facial abnormalities.
- recent gastric or esophageal surgery.
- active upper gastrointestinal bleeding.
- large amount of sputum with weak cough ability
- lack of co-operation.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiated hospital, chongqing medical university
Chongqing, Chongqing Municipality, 400016
About this study
The investigators use a protocol to wean from noninvasive mechanical ventilation.
Read the detailed description
Design: Prospective, randomized, controlled trial, with 2 groups: study (protocol weaning group) and control (clinicians' order weaning group). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients >18 yr, noninvasive mechanical ventilation >24 hours. Interventions and measurements: Study group (weaning as the protocol) and control group (weaning as the clinicians' order); recording of clinical variables at admission and during RICU stay, and end-point variables (noninvasive mechanical ventilation day, RICU and hospital stay, RICU mortality. Expected results: the protocol group's noninvasive mechanical ventilation days is less than clinicians' order group.
- Conditions
- Ventilator Weaning
- Being tested
- protocol, physician's orders
- Keywords
- noninvasive mechanical ventilation, ventilator weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolDevice
Also called In this group, the patients were weaned as the protocol.
In this group, the patients were weaned as the protocol.
physician's ordersOther
Also called In this group, the patients were weaned as the clinicians' order.
In this group, the patients were weaned as the clinicians' order.
| Study group | Role | What they receive |
|---|---|---|
| protocol group | Active comparator | This group patients are weaned as the protocol which the investigators described. Receives: Device: protocol |
| clinicians' order group | Other | This group patients are weaned as the clinicians' order. Receives: Other: physician's orders |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of noninvasive mechanical ventilation
The duration of noninvasive mechanical ventilation was measured from the patients admitted to ICU to discharged from it,an expected average of 4 weeks.
Measured: from admission to ICU to discharge from it (average of 4 weeks)
Secondary outcomes (4)
The successful weaning rate
The successful weaning rate was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.
Measured: from admission to ICU to discharge from it (average of 4 weeks)
The length of ICU days
The length of ICU days was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.
Measured: from admission to ICU to discharge from it (average of 4 weeks)
The intubation rate during the study
The intubation rate during the study was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.
Measured: from admission to ICU to discharge from it (average of 4 weeks)
The mortality during the study
The mortality during the study was measured from the patients admitted to ICU to discharged from it, an expected average of 4 weeks.
Measured: from admission to ICU to discharge from it (average of 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Enough patients has been enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duan jun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duan jun, Chongqing Medical University
- Investigators
- Jun Duan, Principal investigator, The first affiliated hospital, Chongqing medical hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535755
- Sponsor's protocol ID
- cqykdxfsdyyy2
- Status last verified
- Jul 2013
- First submitted
- 11 Feb 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol to Wean From Noninvasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01535755
- Acronym / sponsor ID
- cqykdxfsdyyy2
- Conditions
- Ventilator Weaning
- Keywords
- noninvasive mechanical ventilation, ventilator weaning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enough patients has been enrolled.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duan junUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Feb 2012 (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.
The investigators use a protocol to wean from noninvasive mechanical ventilation.
Detailed description
Design: Prospective, randomized, controlled trial, with 2 groups: study (protocol weaning group) and control (clinicians' order weaning group). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients >18 yr, noninvasive mechanical ventilation >24 hours. Interventions and measurements: Study group (weaning as the protocol) and control group (weaning as the clinicians' order); recording of clinical variables at admission and during RICU stay, and end-point variables (noninvasive mechanical ventilation day, RICU and hospital stay, RICU mortality. Expected results: the protocol group's noninvasive mechanical ventilation days is less than clinicians' order group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protocol group | Active comparator | Device: protocolThis group patients are weaned as the protocol which the investigators described. |
| clinicians' order group | Other | Other: physician's ordersThis group patients are weaned as the clinicians' order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- noninvasive mechanical ventilation > 24 hours.
- age >18 years
Key exclusion criteria (7 listed)
- severe cerebraI，heart，hepatic and renal faiIure.
- facial or cranial trauma or surgery.
- facial abnormalities.
- recent gastric or esophageal surgery.
- active upper gastrointestinal bleeding.
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 |
|---|---|---|
| protocolAlso: In this group, the patients were weaned as the protocol.In this group, the patients were weaned as the protocol. | Device | protocol group |
| physician's ordersAlso: In this group, the patients were weaned as the clinicians' order.In this group, the patients were weaned as the clinicians' order. | Other | clinicians' order group |
Primary outcome
The duration of noninvasive mechanical ventilation
Time frame: from admission to ICU to discharge from it (average of 4 weeks)
The duration of noninvasive mechanical ventilation was measured from the patients admitted to ICU to discharged from it,an expected average of 4 weeks.
4 secondary outcomes
The successful weaning rate
Time frame: from admission to ICU to discharge from it (average of 4 weeks)
The length of ICU days
Time frame: from admission to ICU to discharge from it (average of 4 weeks)
The intubation rate during the study
Time frame: from admission to ICU to discharge from it (average of 4 weeks)
The mortality during the study
Time frame: from admission to ICU to discharge from it (average of 4 weeks)
Results and safety
The study was stopped early (reason given: Enough patients has been enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
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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.
Jun Duan principal investigator
The first affiliated hospital, Chongqing medical hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protocol and physician's orders in people with Ventilator Weaning, run by Duan jun 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Jul 2013. 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?
The study was stopped early (reason given: Enough patients has been enrolled.). Results are not available in the source record.
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?
The duration of noninvasive mechanical ventilation (time frame: from admission to ICU to discharge from it (average of 4 weeks)). 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 16 Jul 2013.