UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006301 |
|---|---|
| Receipt number | R000007462 |
| Scientific Title | Lightwand-assisted insertion of the ProSeal laryngeal mask airway: a comparative study among the digital and gum elastic bougie-guided techniques. |
| Date of disclosure of the study information | 2011/09/07 |
| Last modified on | 2011/09/26 16:27:20 |
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Basic information
Public title
Lightwand-assisted insertion of the ProSeal laryngeal mask airway: a comparative study among the digital and gum elastic bougie-guided techniques.
Acronym
lightwand and ProSeal laryngeal mask airway
Scientific Title
Lightwand-assisted insertion of the ProSeal laryngeal mask airway: a comparative study among the digital and gum elastic bougie-guided techniques.
Scientific Title:Acronym
lightwand and ProSeal laryngeal mask airway
Region
| Asia(except Japan) |
Condition
Condition
patients undergoing elective unilateral percutaneous nephrolithotomy were recruited into the study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the three different techniques to the success rate and complications in the ProSeal laryngeal mask airway insertion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
insertion success rate and insertion time
Key secondary outcomes
complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The ProSeal laryngeal mak airway was inserted by using digital manipulation.
Interventions/Control_2
The ProSeal laryngeal mak airway was inserted with a gum elastic bougie.
Interventions/Control_3
The ProSeal laryngeal mak airway was inserted with a lightwand.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective unilateral percutaneous nephrolithotomy were recruited into the study
Key exclusion criteria
1.had a known or predicted difficult airway
2.had a mouth opening less than 2.5cm
3.had a body mass index greater than 35
4.were at risk of aspiration during induction of anesthesia
5.presence of oropharyngeal pathology that might interfere with insertion of the ProSeal laryngeal mak airway
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chen Jie |
Organization
Third Military Medical University
Division name
Department of Anaesthesiology, Southwest Hospital,
Zip code
Address
Gaotanyan road, Shapingba, Chongqing, China
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Third Military Medical University
Division name
Department of Anaesthesiology, Southwest Hospital,
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Anaesthesiology, Southwest Hospital,
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, Southwest Hospital,
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 07 | Day |
Last modified on
| 2011 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007462
