Difficult Airway IntubationNCT04325997
Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway
A study testing laryngoscope with mouth opener and video laryngoscope with mouth opener in people with Difficult Airway Intubation and Double-lumen Tube, run by Zhuan Zhang at 1 site in China.
Trial summary
How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway Intubation, Double-lumen Tube
- What is being tested?
- laryngoscope with mouth opener and video laryngoscope with mouth opener
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Aug 2019
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of early lung cancer
- Ages ranged from 30 to 80
Who cannot join
- Pregnancy
- Prediction of difficulty in mask ventilation
- Chest X-ray examination of trachea, bronchial anatomical abnormalities or tumor compression caused by trachea/bronchial deformation
- Failure of assessing Arne risk index
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, 225012
About this study
How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video laryngoscope used in combination, to explore whether can shorten the glottis exposure, improve the success rate of the double lumen tube intubation will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to improve the glottis appeared difficult patients with bronchial intubation success rate to provide the reference.
Read the detailed description
A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic department and whose Arne o 'risk index score was at least 7 points were randomly divided into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure time, bronchial intubation time, intubation times, success rate of one intubation, and NRS score of pharyngeal pain 8 hours after surgery were observed and recorded in the three groups, and the hemodynamic changes after intubation were observed and recorded.
- Conditions
- Difficult Airway Intubation, Double-lumen Tube
- Being tested
- laryngoscope with mouth opener, video laryngoscope with mouth opener
- Keywords
- video laryngoscop, double-lumen tube, mouth gag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscope with mouth openerDevice
Double-lumen tube combined with mouth gag for laryngoscope intubation
video laryngoscope with mouth openerDevice
Double-lumen tube combined with mouth gag for video laryngoscope intubation
| Study group | Role | What they receive |
|---|---|---|
| an ordinary laryngos with mouth opener | Experimental | Not described Receives: Device: laryngoscope with mouth opener |
| Video laryngoscopy intubation | No intervention | Not described |
| Video laryngoscope with mouth opener | Experimental | Not described Receives: Device: video laryngoscope with mouth opener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glottis exposure time
Measured: through study completion, an average of 1 minute
Bronchial intubation time
Measured: through study completion,an average of 1 minute
The number of intubation
Measured: through study completion,an average of 1 minute
One-time success rate of intubation
Measured: through study completion,an average of 1 minute
Glottic field grading
Cormack-Lehane grading, C-L1：Can see glottis mostly；C-L2：Only the posterior union of the glottis is visible, not the glottis, and at most the cartilago arytaenoidea is visible when the larynx is lightly pressed；C-L3： can't see any part of the glottis, only the epiglottis； C-L4：No part of the larynx can be seen
Measured: through study completion,an average of 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Mar 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325997
- Sponsor's protocol ID
- 20200207
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway
- ClinicalTrials.gov ID
- NCT04325997
- Acronym / sponsor ID
- 20200207
- Conditions
- Difficult Airway Intubation, Double-lumen Tube
- Keywords
- video laryngoscop, double-lumen tube, mouth gag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 30 Mar 2020 (actual)
- 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.
How to quickly expose glottis and accurately insert double luminal tracheal tube in patients with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia induction.This study through the double cavity bronchial tube visual laryngoscope intubation with open mouth and electronic video laryngoscope used in combination, to explore whether can shorten the glottis exposure, improve the success rate of the double lumen tube intubation will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to improve the glottis appeared difficult patients with bronchial intubation success rate to provide the reference.
Detailed description
A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic department and whose Arne o 'risk index score was at least 7 points were randomly divided into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure time, bronchial intubation time, intubation times, success rate of one intubation, and NRS score of pharyngeal pain 8 hours after surgery were observed and recorded in the three groups, and the hemodynamic changes after intubation were observed and recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| an ordinary laryngos with mouth opener | Experimental | Device: laryngoscope with mouth opener |
| Video laryngoscopy intubation | No intervention | – |
| Video laryngoscope with mouth opener | Experimental | Device: video laryngoscope with mouth opener |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of early lung cancer
- Ages ranged from 30 to 80
Key exclusion criteria (4 listed)
- Pregnancy
- Prediction of difficulty in mask ventilation
- Chest X-ray examination of trachea, bronchial anatomical abnormalities or tumor compression caused by trachea/bronchial deformation
- Failure of assessing Arne risk index
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 |
|---|---|---|
| laryngoscope with mouth openerDouble-lumen tube combined with mouth gag for laryngoscope intubation | Device | an ordinary laryngos with mouth opener |
| video laryngoscope with mouth openerDouble-lumen tube combined with mouth gag for video laryngoscope intubation | Device | Video laryngoscope with mouth opener |
Primary outcome
Glottis exposure time
Time frame: through study completion, an average of 1 minute
Bronchial intubation time
Time frame: through study completion,an average of 1 minute
The number of intubation
Time frame: through study completion,an average of 1 minute
One-time success rate of intubation
Time frame: through study completion,an average of 1 minute
Glottic field grading
Time frame: through study completion,an average of 1 minute
Cormack-Lehane grading, C-L1：Can see glottis mostly；C-L2：Only the posterior union of the glottis is visible, not the glottis, and at most the cartilago arytaenoidea is visible when the larynx is lightly pressed；C-L3： can't see any part of the glottis, only the epiglottis； C-L4：No part of the larynx can be seen
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 30 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngoscope with mouth opener and video laryngoscope with mouth opener in people with Difficult Airway Intubation and Double-lumen Tube, run by Zhuan Zhang 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 4 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 30 Mar 2020. 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 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?
Glottis exposure time (time frame: through study completion, an average of 1 minute). The study lists 5 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 30 Mar 2020.