Respiratory FailureFBAIDNIPPVNCT02462668
Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
A study testing Bag-mask ventilation, Noninvasive positive pressure ventilation(NIPPV) and fibreoptic bronchoscopy assisted intubation in people with Respiratory Failure, run by Lingbo Nong at 1 site in China.
Trial summary
This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. Half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during NIPPV. 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?
- Bag-mask ventilation, Noninvasive positive pressure ventilation(NIPPV) and fibreoptic bronchoscopy assisted intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to 18 Jun 2017
- 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
- Acute respiratory failure requiring intubation,
- Age greater than or equal to 18 years
Who cannot join
- Nasal polyps，Nasopharyngeal cancer，Nasal bleeding，Rhinitis，Sinusitis and so on Nasal disease
- Basal skull fracture
- Severe coagulopathy, blood platelet counts <50×10*9/L
- Nose and facial deformities, trauma
- Cardiac arrest
- Pregnancy or puerpera
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: The Efficiency and Safety of Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. Half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual preoxygenation(bag-mask ventilation ).
Read the detailed description
Respiratory failure is very common for critically ill patients, Main complication associated with intubation was desaturation. Usual preoxygenation( bag-mask ventilation) have been show that marginally effective in critically ill patients. As a result, there is a need to optimize the technique of preoxygenation to prolong the safe duration of apnea during the intubation procedure in critically ill patients. Noninvasive ventilation provides continuous positive airway pressure is effective in increasing the efficiency of gas exchange and in reducing the decrease in oxyhemoglobin saturation during fiberoptic bronchoscopy in hypoxemic patients.
Therefore, our aim was to study whether NIPPV is more effective at reducing desaturation than usual preoxygenation in hypoxemic, critically ill patients requiring intubation in ICU.
- Conditions
- Respiratory Failure
- Being tested
- Bag-mask ventilation, Noninvasive positive pressure ventilation(NIPPV), fibreoptic bronchoscopy assisted intubation
- Keywords
- Bronchoscopy, Intubation, Noninvasive positive pressure ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag-mask ventilationProcedure or surgery
The control group receives preoxygenation with bag-mask ventilation
Noninvasive positive pressure ventilation(NIPPV)Procedure or surgery
The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation
fibreoptic bronchoscopy assisted intubationProcedure or surgery
All patients will receive fibreoptic bronchoscopy assisted intubation.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Preoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation.
Intervention: Bag-mask ventilation. Receives: Procedure: Bag-mask ventilation; Procedure: fibreoptic bronchoscopy assisted intubation |
| NIPPV | Experimental | The NIPPV group preoxygenation with noninvasive positive pressure ventilation(NIPPV), And then receives fibreoptic bronchoscopy intubation through a face mask (there is a small hole allow to insert the tracheal tube through the mask into trachea) during NIPPV.
Intervention: noninvasive positive pressure ventilation(NIPPV) Receives: Procedure: Noninvasive positive pressure ventilation(NIPPV); Procedure: fibreoptic bronchoscopy assisted intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulse oxymetry(SpO2)
Measured: From time of randomization until connect to ventilator 30min
Secondary outcomes (1)
Mechanical ventilation Time
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 posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion11 Jun 2017
- Study completion18 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lingbo Nong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingbo Nong, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, investigator, Study director, The First Hospital Of Guangzhou Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462668
- Sponsor's protocol ID
- LNong
- Acronym
- FBAIDNIPPV
- Status last verified
- Aug 2017
- First submitted
- 24 May 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nong L, Liang W, Yu Y, Xi Y, Liu D, Zhang J, Zhou J, Yang C, He W, Liu X, Li Y, Chen R. Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia. J Crit Care. 2020 Apr;56:12-17. doi: 10.1016/j.jcrc.2019.10.017. Epub 2019 Nov 14.
PubMed 31785505
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Safety of Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure Ventilation
- ClinicalTrials.gov ID
- NCT02462668
- Acronym / sponsor ID
- FBAIDNIPPV / LNong
- Conditions
- Respiratory Failure
- Keywords
- Bronchoscopy, Intubation, Noninvasive positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lingbo NongUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 18 Jun 2017 (actual)
- First posted
- 4 Jun 2015 (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.
This study is to investigate the efficiency and safety of fibreoptic bronchoscopy assisted intubation during noninvasive positive pressure ventilation in respiratory failure patients. Half of the participants will receive preoxygenation with noninvasive ventilator and fibreoptic bronchoscopy intubation during NIPPV. While the other half using usual preoxygenation(bag-mask ventilation ).
Detailed description
Respiratory failure is very common for critically ill patients, Main complication associated with intubation was desaturation. Usual preoxygenation( bag-mask ventilation) have been show that marginally effective in critically ill patients. As a result, there is a need to optimize the technique of preoxygenation to prolong the safe duration of apnea during the intubation procedure in critically ill patients. Noninvasive ventilation provides continuous positive airway pressure is effective in increasing the efficiency of gas exchange and in reducing the decrease in oxyhemoglobin saturation during fiberoptic bronchoscopy in hypoxemic patients.
Therefore, our aim was to study whether NIPPV is more effective at reducing desaturation than usual preoxygenation in hypoxemic, critically ill patients requiring intubation in ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Bag-mask ventilation, Procedure: fibreoptic bronchoscopy assisted intubationPreoxygenation with Bag-mask ventilation before fibreoptic bronchoscopy assisted intubation. Intervention: Bag-mask ventilation. |
| NIPPV | Experimental | Procedure: Noninvasive positive pressure ventilation(NIPPV), Procedure: fibreoptic bronchoscopy assisted intubationThe NIPPV group preoxygenation with noninvasive positive pressure ventilation(NIPPV), And then receives fibreoptic bronchoscopy intubation through a face mask (there is a small hole allow to insert the tracheal tube through the mask into trachea) during NIPPV. Intervention: noninvasive positive pressure ventilation(NIPPV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute respiratory failure requiring intubation,
- Age greater than or equal to 18 years
Key exclusion criteria (6 listed)
- Nasal polyps，Nasopharyngeal cancer，Nasal bleeding，Rhinitis，Sinusitis and so on Nasal disease
- Basal skull fracture
- Severe coagulopathy, blood platelet counts <50×10*9/L
- Nose and facial deformities, trauma
- Cardiac 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 |
|---|---|---|
| Bag-mask ventilationThe control group receives preoxygenation with bag-mask ventilation | Procedure or surgery | Control |
| Noninvasive positive pressure ventilation(NIPPV)The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation | Procedure or surgery | NIPPV |
| fibreoptic bronchoscopy assisted intubationAll patients will receive fibreoptic bronchoscopy assisted intubation. | Procedure or surgery | Control, NIPPV |
Primary outcome
Change in pulse oxymetry(SpO2)
Time frame: From time of randomization until connect to ventilator 30min
1 secondary outcome
Mechanical ventilation Time
Time frame: 28 days
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 4 Aug 2017.
- Derived from this study: PubMed 31785505Nong L, Liang W, Yu Y, Xi Y, Liu D, Zhang J, Zhou J, Yang C, He W, Liu X, Li Y, Chen R. Noninvasive ventilation support during fiberoptic bronchoscopy-guided nasotracheal intubation effectively prevents severe hypoxemia. J Crit Care. 2020 Apr;56:12-17. doi: 10.1016/j.jcrc.2019.10.017. Epub 2019 Nov 14.
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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.
Rongchang Chen, investigator study director
The First Hospital Of Guangzhou Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bag-mask ventilation, Noninvasive positive pressure ventilation(NIPPV) and fibreoptic bronchoscopy assisted intubation in people with Respiratory Failure, run by Lingbo Nong 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 6 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 4 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Change in pulse oxymetry(SpO2) (time frame: From time of randomization until connect to ventilator 30min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462668, which also lists 1 linked publication.
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 4 Aug 2017.