General Anesthesia With Laryngeal Mask Airway (LMA)NCT01407302
Optimal Head Rotation and External Landmark for Internal Jugular Vein Cannulation After Placement of Proseal Laryngeal Mask Airway
An observational study of General Anesthesia With Laryngeal Mask Airway (LMA), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Recently, laryngeal mask airway (LMA) placements are frequently performed for general anesthesia. The investigators occasionally encounter a clinical situation to perform internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in subjects undergoing major surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- General Anesthesia With Laryngeal Mask Airway (LMA)
- What is being tested?
- Head rotation
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Dec 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing general anesthesia with laryngeal mask airway insertion
Who may be able to join
- patients undergoing general anesthesia with laryngeal mask airway insertion
Who cannot join
- patients undergoing emergency surgery
- patients with anatomical problem of airway
- anticipated difficult airway
- patients with hemodynamic unstability
- patients with severe cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Recently, laryngeal mask airway (LMA) placements are frequently performed for general anesthesia. The investigators occasionally encounter a clinical situation to perform internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in subjects undergoing major surgery. However, anatomic relations of IJV and common carotid artery (CCA) in patient with LMA placement have been reported to be different from those in patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA placement was greater than before LMA placement. Furthermore, there are many cases of complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore, the central landmark commonly used for IJV cannulation was proved to show low success rate after LMA placement in previous report.
The investigators carefully examined the anatomic relations of IJV and CCA after LMA insertion with ultrasonography, and found that the degree of overlapping is different according to the degree of head rotation. The investigators postulated that if the degree of overlapping is different according to the degree of head rotation after LMA insertion, the investigators can find the angle of head rotation for least overlapping and reduce the risk of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark adequate for IJV cannulation after LMA placement.
Read the detailed description
Recently, laryngeal mask airway (LMA) placements are frequently performed for general anesthesia. The investigators occasionally encounter a clinical situation to perform internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in subjects undergoing major surgery. However, anatomic relations of IJV and common carotid artery (CCA) in patient with LMA placement have been reported to be different from those in patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA placement was greater than before LMA placement. Furthermore, there are many cases of complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore, the central landmark commonly used for IJV cannulation was proved to show low success rate after LMA placement in previous report. Previous study recommended the lower puncture point near that area where the clavicular head of the sternocleidomastoid muscle attaches to the clavicle, because CCA was not observed in the vicinity of the IJV after LMA insertion. Even though they performed test puncture at the lower puncture point in 20 patients and found no complications, the lower puncture point is not the usual site for IJV cannulation for most anesthesiologists. It is known that increased head rotation is associated with high probability of CCA contact. The investigators carefully examined the anatomic relations of IJV and CCA after LMA insertion with ultrasonography, and found that the degree of overlapping is different according to the degree of head rotation. The investigators postulated that if the degree of overlapping is different according to the degree of head rotation after LMA insertion, the investigators can find the angle of head rotation for least overlapping and reduce the risk of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark adequate for IJV cannulation after LMA placement.
- Being tested
- Head rotation
- Keywords
- Laryngeal mask airway, internal jugular vein cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head rotationOther
Repeated ultrasonographic examination according to the degree of head rotation (examination of overlap index of internal jugular vein and common carotid artery, and accuracy of external landmark of jugular cannulation)
| Study group | Role | What they receive |
|---|---|---|
| LMA group | patients undergoing general anesthesia with LMA insertion Receives: Other: Head rotation | |
| E-tube group | patients undergoing general anesthesia with e-tube Receives: Other: Head rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overlap index
The overlap index was derived from the ratio of the overlapping length of the IJV to the horizontal diameter of the CCA measured on the ultrasonographic image. The formula of calculation is as follows: overlap index = [overlap length (mm)/ CCA diameter (mm)] X 100(%), the measurements were repeated according to the degree of head rotation (neutral, 15 degree, 30 degree, 45 degree)
Measured: at 5 min after anesthesia induction
Secondary outcomes (2)
The success of simulated internal jugular vein puncture (central landmark)
The success of internal jugular vein puncture guided by the central landmark simulated on the ultrasonographic images, the measurements were repeated according to the degree of head rotation (neutral, 15 degree, 30 degree, 45 degree)
Measured: at 5 min after anesthesia induction
The success of simulated internal jugular vein puncture (external jugular vein landmark)
The success of internal jugular vein puncture as guided by 1.5 cm or 2.5 cm medial to the external jugular vein simulated on the ultrasonographic images, the measurements were repeated according to the degree of head rotation (neutral, 15 degrees, 30 degrees, 45 degrees)
Measured: at 5 min after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia With Laryngeal Mask Airway (LMA)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwak Mi Sook, Samsung Medical Center
- Investigators
- Mi Sook Gwak, M.D.,Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407302
- Sponsor's protocol ID
- 2011-04-024
- Status last verified
- Dec 2013
- First submitted
- 21 Jul 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Head Rotation and External Landmark for Internal Jugular Vein Cannulation After Placement of Proseal Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT01407302
- Acronym / sponsor ID
- 2011-04-024
- Keywords
- Laryngeal mask airway, internal jugular vein cannulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Aug 2011 (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.
Recently, laryngeal mask airway (LMA) placements are frequently performed for general anesthesia. The investigators occasionally encounter a clinical situation to perform internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in subjects undergoing major surgery. However, anatomic relations of IJV and common carotid artery (CCA) in patient with LMA placement have been reported to be different from those in patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA placement was greater than before LMA placement. Furthermore, there are many cases of complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore, the central landmark commonly used for IJV cannulation was proved to show low success rate after LMA placement in previous report.
The investigators carefully examined the anatomic relations of IJV and CCA after LMA insertion with ultrasonography, and found that the degree of overlapping is different according to the degree of head rotation. The investigators postulated that if the degree of overlapping is different according to the degree of head rotation after LMA insertion, the investigators can find the angle of head rotation for least overlapping and reduce the risk of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark adequate for IJV cannulation after LMA placement.
Detailed description
Recently, laryngeal mask airway (LMA) placements are frequently performed for general anesthesia. The investigators occasionally encounter a clinical situation to perform internal jugular vein (IJV) cannulation after LMA insertion, especially for difficult airway in subjects undergoing major surgery. However, anatomic relations of IJV and common carotid artery (CCA) in patient with LMA placement have been reported to be different from those in patients with endotracheal tube. The degree of overlapping of the right IJV and CCA after LMA placement was greater than before LMA placement. Furthermore, there are many cases of complete overlapping right IJV and CCA after LMA placement. Therefore, the risk of puncturing CCA increases when the investigators try to cannulate IJV after LMA placement. Furthermore, the central landmark commonly used for IJV cannulation was proved to show low success rate after LMA placement in previous report. Previous study recommended the lower puncture point near that area where the clavicular head of the sternocleidomastoid muscle attaches to the clavicle, because CCA was not observed in the vicinity of the IJV after LMA insertion. Even though they performed test puncture at the lower puncture point in 20 patients and found no complications, the lower puncture point is not the usual site for IJV cannulation for most anesthesiologists. It is known that increased head rotation is associated with high probability of CCA contact. The investigators carefully examined the anatomic relations of IJV and CCA after LMA insertion with ultrasonography, and found that the degree of overlapping is different according to the degree of head rotation. The investigators postulated that if the degree of overlapping is different according to the degree of head rotation after LMA insertion, the investigators can find the angle of head rotation for least overlapping and reduce the risk of CCA puncture. Therefore, the investigators tried (1) to find the optimal head rotation angle appropriate for puncturing IJV after LMA placement, and (2) to find suitable landmark adequate for IJV cannulation after LMA placement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA group | – | Other: Head rotationpatients undergoing general anesthesia with LMA insertion |
| E-tube group | – | Other: Head rotationpatients undergoing general anesthesia with e-tube |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing general anesthesia with laryngeal mask airway insertion
Key inclusion criteria (1 listed)
- patients undergoing general anesthesia with laryngeal mask airway insertion
Key exclusion criteria (5 listed)
- patients undergoing emergency surgery
- patients with anatomical problem of airway
- anticipated difficult airway
- patients with hemodynamic unstability
- patients with severe cardiopulmonary disease
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 |
|---|---|---|
| Head rotationRepeated ultrasonographic examination according to the degree of head rotation (examination of overlap index of internal jugular vein and common carotid artery, and accuracy of external landmark of jugular cannulation) | Other | E-tube group, LMA group |
Primary outcome
overlap index
Time frame: at 5 min after anesthesia induction
The overlap index was derived from the ratio of the overlapping length of the IJV to the horizontal diameter of the CCA measured on the ultrasonographic image. The formula of calculation is as follows: overlap index = [overlap length (mm)/ CCA diameter (mm)] X 100(%), the measurements were repeated according to the degree of head rotation (neutral, 15 degree, 30 degree, 45 degree)
2 secondary outcomes
The success of simulated internal jugular vein puncture (central landmark)
Time frame: at 5 min after anesthesia induction
The success of simulated internal jugular vein puncture (external jugular vein landmark)
Time frame: at 5 min after anesthesia induction
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 25 Dec 2013.
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.
Mi Sook Gwak, M.D.,Ph.D. principal investigator
Samsung Medical Center
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 General Anesthesia With Laryngeal Mask Airway (LMA), run by Samsung Medical Center at 1 site in South Korea.
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 5 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 25 Dec 2013. 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 South Korea. 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?
overlap index (time frame: at 5 min after anesthesia induction). 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 25 Dec 2013; AzTrials last refreshed its copy on 2 Nov 2026.