UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018077 |
|---|---|
| Receipt number | R000020892 |
| Scientific Title | A comparison of King Vision video laryngoscopy and direct laryngoscopy as performed by residents |
| Date of disclosure of the study information | 2015/06/25 |
| Last modified on | 2015/06/25 01:28:04 |
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Basic information
Public title
A comparison of King Vision video laryngoscopy and direct laryngoscopy as performed by residents
Acronym
KVVL versus DL by first year residents
Scientific Title
A comparison of King Vision video laryngoscopy and direct laryngoscopy as performed by residents
Scientific Title:Acronym
KVVL versus DL by first year residents
Region
| South America |
Condition
Condition
Patients with no predictors of difficult airway were randomized to intubation by direct laryngoscopy or by King Vision video laryngoscopy
Classification by specialty
| Medicine in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of the King Vision video laryngoscope versus direct laryngoscopy for endotracheal intubation in patients with no predictors of difficult airway by Anesthesiology first year residents at University Hospital Fundacion Santa Fe de Bogota during the year 2013
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the efficacy of the King Vision video laryngoscope versus direct laryngoscopy for endotracheal intubation in patients with no predictors of difficult airway by Anesthesiology first year residents at University Hospital Fundacion Santa Fe de Bogota during the year 2013
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Intubation by King Vision video laryngoscopy
Interventions/Control_2
Intubation by Direct Laryngoscopy
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elective surgery under general anesthesia requiring endotracheal intubation
ASA I-II
Accepted participation in the study
Key exclusion criteria
Suspected full stomach (Incomplete fasting, chronic opioid use, uncompensated diabetes, obstructive abdominal pathology or ileus)
Mouth opening < 4 cm
Cervical flexion and extension limitations
Mallampati IV
Difficult ventilation prior to intubation
Known difficult airway
Presence of cervical lesion
Presence of masses or neoplasms in airway
Craniofacial deformity
Any other reason raised by the anesthesiologist
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jose Alejandro Valencia |
Organization
Hospital Fundacion Santa Fe de Bogota, Bogota, Colombia
Division name
Anesthesiology
Zip code
Address
Carrera 7 No. 117-15, Bogota, Colombia
TEL
5716030303
anestesia@fsfb.org.co
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | David Romero |
Organization
Hospital Fundacion Santa Fe de Bogota, Bogota, Colombia
Division name
Anesthesiology
Zip code
Address
Carrera 7 No. 117-15, Bogota, Colombia
TEL
5716030303
Homepage URL
dromerom89@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Hospital Fundacion Santa Fe de Bogota
Institute
Department
Personal name
Funding Source
Organization
Institutional funding
Organization
Division
Category of Funding Organization
Non profit foundation
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
Hospital Universitario Fundacion Santa Fe de Bogota
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 25 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | 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
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020892
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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