Transillumination-guided Fiberoptic Intubation IntubationNCT01129726
Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Success Rate and Time in Untrained Medical Personnel
A study testing Transillumination-guided Fiberoptic Intubation in people with Transillumination-guided Fiberoptic Intubation Intubation, run by Second Military Medical University at 2 sites in China.
Trial summary
Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Transillumination-guided Fiberoptic Intubation Intubation
- What is being tested?
- Transillumination-guided Fiberoptic Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- May 2010to Dec 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- general anesthesia
- ASA I~II
- Mallampati Score grade I~II
- thyromental distance ≥6cm
- mouth-open ≥3cm
- body mass index (BMI) ≤30kg/m2
Who cannot join
- neck and maxillofacial surgeries
- potential risks for regurgitation and pulmonary aspiration
- in pregnancy
Trial locations and contacts
2 sites in 1 country.
China2 sites
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, 200433
Changhai Hospital affiliated to Second Military Medical University
Shanghai, 200433
About this study
Official title: Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Time and Success Rate in Untrained Medical Personnel
Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want to know if the Transillumination-guided Fiberoptic Intubation technique can improves the success rate and time for tracheal intubation performed by inexperienced anesthesiologists; whether this technique improves the success rate and for normal intubations when performed by inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.
- Being tested
- Transillumination-guided Fiberoptic Intubation
- Keywords
- Transillumination-guided, Fiberoptic Intubation, time, success rate, intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transillumination-guided Fiberoptic IntubationDevice
Also called Light guided Bronchoscopic Intubation Technique
Light guided, Non-invasive
| Study group | Role | What they receive |
|---|---|---|
| Intubation | Experimental | Transillumination-guided Fiberoptic Intubation Receives: Device: Transillumination-guided Fiberoptic Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Measured: Within 3 month
Secondary outcomes (1)
success rate and postoperative side effect
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transillumination-guided Fiberoptic Intubation IntubationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Tao, Second Military Medical University
- Investigators
- XiaoMing Deng, Ph.D., Study chair, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129726
- Sponsor's protocol ID
- 20100002
- Other IDs
- Light Guided
- Status last verified
- Feb 2012
- First submitted
- 18 May 2010
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Time and Success Rate in Untrained Medical Personnel
- ClinicalTrials.gov ID
- NCT01129726
- Acronym / sponsor ID
- 20100002
- Keywords
- Transillumination-guided, Fiberoptic Intubation, time, success rate, intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2010 (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.
Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want to know if the Transillumination-guided Fiberoptic Intubation technique can improves the success rate and time for tracheal intubation performed by inexperienced anesthesiologists; whether this technique improves the success rate and for normal intubations when performed by inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubation | Experimental | Device: Transillumination-guided Fiberoptic IntubationTransillumination-guided Fiberoptic Intubation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- general anesthesia
- ASA I~II
- Mallampati Score grade I~II
- thyromental distance ≥6cm
- mouth-open ≥3cm
Key exclusion criteria (3 listed)
- neck and maxillofacial surgeries
- potential risks for regurgitation and pulmonary aspiration
- in pregnancy
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 |
|---|---|---|
| Transillumination-guided Fiberoptic IntubationAlso: Light guided Bronchoscopic Intubation TechniqueLight guided, Non-invasive | Device | Intubation |
Primary outcome
time to intubation
Time frame: Within 3 month
1 secondary outcome
success rate and postoperative side effect
Time frame: 2 months
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 Feb 2012.
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.
XiaoMing Deng, Ph.D. study chair
Second Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transillumination-guided Fiberoptic Intubation in people with Transillumination-guided Fiberoptic Intubation Intubation, run by Second Military 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 6 inclusion and 3 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 Feb 2012. 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?
time to intubation (time frame: Within 3 month). 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 Feb 2012.