Respiratory FailureNCT01900990
Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients
A study testing Noninvasive ventilation weaning in people with Respiratory Failure, run by Chongqing Medical University at 2 sites in China.
Trial summary
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Noninvasive ventilation weaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2009to Oct 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
- age ≥ 18 years
- tracheotomy mechanical ventilation patients
Who cannot join
- pregnancy
- respiratory and hemodynamic instability
- Recent oral，nasal，facial or cranial trauma or surgery
- contra-indications for nasal or facial mask (facial skin lesions,...)
- recent history of upper gastro-intestinal surgery
- recent history of myocardial infarction
- unconscious patients
- non cooperative patient
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital ,Chongqing Medical Univercity
Chongqing, Chongqing Municipality, 400016
The First Affiliated Hospital ,Chongqing Medical Univercity
Chongqing, Chongqing Municipality, 40016
About this study
Official title: A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.
Read the detailed description
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.
- Conditions
- Respiratory Failure
- Being tested
- Noninvasive ventilation weaning
- Keywords
- Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilation weaningDevice
Also called capping tracheotomy tube
We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation weaning | Experimental | Patients in this group were weaned by noninvasive ventilation Receives: Device: Noninvasive ventilation weaning |
| Conventional weaning | No intervention | Patients in this group were weaned by conventional stratiges. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main end-point defined as total duration of mechanical ventilation
The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
Secondary outcomes (6)
duration of invasive mechanical ventilation
The duration of invasive mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
duration of extubation tracheotomy tube
The duration of extubation tracheotomy tube was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
total duration of mechanical ventilation (invasive and non invasive)
The total duration of mechanical ventilation (invasive and non invasive) was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
successful weaning rate
The sucessful weaning rate was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
ICU length of stay
The ICU lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
hospital length of stay
The hospital lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
Measured: from admission to hospital to discharge from it or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duan jun, Chongqing Medical University
- Investigators
- Duan Jun, Principal investigator, The First Affiliated Hospital,Chongqing Medical Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900990
- Sponsor's protocol ID
- CQYKDXFSDYYY
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2010
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients
- ClinicalTrials.gov ID
- NCT01900990
- Acronym / sponsor ID
- CQYKDXFSDYYY
- Conditions
- Respiratory Failure
- Keywords
- Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Jul 2013 (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 adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.
Detailed description
The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation weaning | Experimental | Device: Noninvasive ventilation weaningPatients in this group were weaned by noninvasive ventilation |
| Conventional weaning | No intervention | –Patients in this group were weaned by conventional stratiges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- tracheotomy mechanical ventilation patients
Key exclusion criteria (8 listed)
- pregnancy
- respiratory and hemodynamic instability
- Recent oral，nasal，facial or cranial trauma or surgery
- contra-indications for nasal or facial mask (facial skin lesions,...)
- recent history of upper gastro-intestinal surgery
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 |
|---|---|---|
| Noninvasive ventilation weaningAlso: capping tracheotomy tubeWe adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff | Device | Noninvasive ventilation weaning |
Primary outcome
Main end-point defined as total duration of mechanical ventilation
Time frame: from admission to hospital to discharge from it or death
The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
6 secondary outcomes
duration of invasive mechanical ventilation
Time frame: from admission to hospital to discharge from it or death
duration of extubation tracheotomy tube
Time frame: from admission to hospital to discharge from it or death
total duration of mechanical ventilation (invasive and non invasive)
Time frame: from admission to hospital to discharge from it or death
successful weaning rate
Time frame: from admission to hospital to discharge from it or death
ICU length of stay
Time frame: from admission to hospital to discharge from it or death
hospital length of stay
Time frame: from admission to hospital to discharge from it or death
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 17 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.
Duan Jun principal investigator
The First Affiliated Hospital,Chongqing Medical Univercity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation weaning in people with Respiratory Failure, run by Chongqing Medical University at 2 sites 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 8 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 17 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 2 sites 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 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?
Main end-point defined as total duration of mechanical ventilation (time frame: from admission to hospital to discharge from it or death). 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 17 Jul 2013.