Intubation; DifficultNCT01984970
McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
An observational study of Intubation; Difficult and Intubation Complication, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
1. Double-lumen tube intubation is difficult, compared with single lume tube. 2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients. 3. But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intubation; Difficult, Intubation Complication
- What is being tested?
- videolaryngoscope
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Jan 2014
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation
Who may be able to join
- adult patients
- thoracic surgery
- ASA classification 1-3
Who cannot join
- Emergent operation
- predicted difficult airway
- difficult ventilation
- limited mouth opening
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Evaluation McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
- Double-lumen tube intubation is difficult, compared with single lume tube.
- McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients.
- But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation.
Read the detailed description
In this study, the purpose was to evaluate the success rate and intubation time of McGrath Series 5 videolaryngoscope for double-lumen tube intubation in patients without predictors of difficult intubation.
- Conditions
- Intubation; Difficult, Intubation Complication
- Being tested
- videolaryngoscope
- Keywords
- McGrath Videolaryngoscope, double-lumen tube intubation, Thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videolaryngoscopeDevice
McGrath Series 5 videolaryngoscope is one kind of portable videolaryngoscopes, which has been usde in both unexpected and anticipated difficult intubation.
| Study group | Role | What they receive |
|---|---|---|
| videolaryngoscope | The patients received videolaryngoscope for double-lumen tube intubation Receives: Device: videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
defined as time from inserting blade to mouth to three cycles on capnograph
Measured: at intubation
Secondary outcomes (1)
number of successful intubation at first attempt
Measured: at intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
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 Intubation; DifficultStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenlong Yao, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, Ph.D.,M.D., Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984970
- Sponsor's protocol ID
- 20121126001
- Status last verified
- Jul 2014
- First submitted
- 1 Nov 2013
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yao WL, Wang XR, Xu H, Zhang Y, Zhang CH. McGrath((R)) series 5 videolaryngoscope evaluation for double-lumen tube intubation. Anaesthesia. 2014 Jun;69(6):646-7. doi: 10.1111/anae.12720. No abstract available.
PubMed 24813140
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
- ClinicalTrials.gov ID
- NCT01984970
- Acronym / sponsor ID
- 20121126001
- Conditions
- Intubation; Difficult, Intubation Complication
- Keywords
- McGrath Videolaryngoscope, double-lumen tube intubation, Thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Nov 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.
- Double-lumen tube intubation is difficult, compared with single lume tube.
- McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients.
- But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation.
Detailed description
In this study, the purpose was to evaluate the success rate and intubation time of McGrath Series 5 videolaryngoscope for double-lumen tube intubation in patients without predictors of difficult intubation.
Study design
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| videolaryngoscope | – | Device: videolaryngoscopeThe patients received videolaryngoscope for double-lumen tube intubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation
Key inclusion criteria (3 listed)
- adult patients
- thoracic surgery
- ASA classification 1-3
Key exclusion criteria (4 listed)
- Emergent operation
- predicted difficult airway
- difficult ventilation
- limited mouth opening
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 |
|---|---|---|
| videolaryngoscopeMcGrath Series 5 videolaryngoscope is one kind of portable videolaryngoscopes, which has been usde in both unexpected and anticipated difficult intubation. | Device | videolaryngoscope |
Primary outcome
intubation time
Time frame: at intubation
defined as time from inserting blade to mouth to three cycles on capnograph
1 secondary outcome
number of successful intubation at first attempt
Time frame: at intubation
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 14 Jul 2014.
- Results publication: PubMed 24813140Yao WL, Wang XR, Xu H, Zhang Y, Zhang CH. McGrath((R)) series 5 videolaryngoscope evaluation for double-lumen tube intubation. Anaesthesia. 2014 Jun;69(6):646-7. doi: 10.1111/anae.12720. No abstract available.
Related trials for Intubation; Difficult
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
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.
Yuke Tian, Ph.D.,M.D. study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation; Difficult and Intubation Complication, run by Huazhong University of Science and Technology 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 3 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 14 Jul 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?
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?
intubation time (time frame: at intubation). 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 NCT01984970, 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 14 Jul 2014.