Noninvasive Positive Pressure Ventilation;NCT02289586
Interventional Bronchoscopy Under Noninvasive Ventilation
A study testing invasive ventilation, interventional bronchoscopy and noninvasive ventilation in people with Noninvasive Positive Pressure Ventilation; and Sedation;, run by Futian People's Hospital at 1 site in China.
Trial summary
To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis. With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；
- What is being tested?
- invasive ventilation, interventional bronchoscopy and noninvasive ventilation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Feb 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Who cannot join
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Futian People's Hospital
Shenzhen, Guangdong, 518033
Xiao-ke Chen, master, +86-755-83982222 ext. 32070, 007cxk@163.com
About this study
Official title: Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis
To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.
With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.
- Conditions
- Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；, Interventional；, Central Airway Stenosis
- Being tested
- invasive ventilation, interventional bronchoscopy, noninvasive ventilation, sedation(dezocine and midazolam), general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
invasive ventilationProcedure or surgery
interventional bronchoscopyProcedure or surgery
noninvasive ventilationDevice
sedation(dezocine and midazolam)Drug
general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）Drug
| Study group | Role | What they receive |
|---|---|---|
| hypoxemia, central airway stenosis. | Active comparator | Inclusion Criteria:
* (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
* (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. Receives: Procedure: invasive ventilation; Procedure: interventional bronchoscopy; Drug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil） |
| hypoxemia, central airway stenosis | Experimental | Inclusion Criteria:
* (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
* (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. Receives: Procedure: interventional bronchoscopy; Device: noninvasive ventilation; Drug: sedation(dezocine and midazolam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of airway stenosis after the operation
Measured: 1 day
The improvement of partial pressure of arterial oxygen (PaO2) after the operation
Measured: 1 day
Secondary outcomes (2)
hospitalization expenses
Measured: During the period of hospitalization，an expected average of 4 weeks
hypoxemia during the operation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive Positive Pressure Ventilation;Studies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Futian People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Science and Technology Innovation Commission of Shenzhen Municipality
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289586
- Sponsor's protocol ID
- szkcw-2014-322
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis
- ClinicalTrials.gov ID
- NCT02289586
- Acronym / sponsor ID
- szkcw-2014-322
- Conditions
- Noninvasive Positive Pressure Ventilation;, Sedation;, Bronchoscopy；, Interventional；, Central Airway Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Futian People's HospitalUniversity, hospital or other
- Collaborators
- Science and Technology Innovation Commission of Shenzhen Municipality
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (estimated)
- First posted
- 13 Nov 2014 (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.
To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.
With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypoxemia, central airway stenosis. | Active comparator | Procedure: invasive ventilation, Procedure: interventional bronchoscopy, Drug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. |
| hypoxemia, central airway stenosis | Experimental | Procedure: interventional bronchoscopy, Device: noninvasive ventilation, Drug: sedation(dezocine and midazolam)Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Key exclusion criteria (1 listed)
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
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 |
|---|---|---|
| invasive ventilation | Procedure or surgery | hypoxemia, central airway stenosis. |
| interventional bronchoscopy | Procedure or surgery | hypoxemia, central airway stenosis, hypoxemia, central airway stenosis. |
| noninvasive ventilation | Device | hypoxemia, central airway stenosis |
| sedation(dezocine and midazolam) | Drug | hypoxemia, central airway stenosis |
| general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil） | Drug | hypoxemia, central airway stenosis. |
Primary outcome
The improvement of airway stenosis after the operation
Time frame: 1 day
The improvement of partial pressure of arterial oxygen (PaO2) after the operation
Time frame: 1 day
2 secondary outcomes
hospitalization expenses
Time frame: During the period of hospitalization，an expected average of 4 weeks
hypoxemia during the operation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
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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 invasive ventilation, interventional bronchoscopy and noninvasive ventilation in people with Noninvasive Positive Pressure Ventilation; and Sedation;, run by Futian People's Hospital 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 1 inclusion and 1 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 13 Nov 2014. 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 Xiao-ke Chen, Master (+86-755-83982222 ext. 32070, 007cxk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of airway stenosis after the operation (time frame: 1 day). The study lists 2 primary outcomes in all. 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 13 Nov 2014.