UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044474 |
|---|---|
| Receipt number | R000050808 |
| Scientific Title | A Comparative study of the efficacy of Glidescope versus Macintosh direct laryngoscopy for intubation in pediatric patients undergoing cardiac surgery |
| Date of disclosure of the study information | 2021/06/22 |
| Last modified on | 2021/06/21 23:33:34 |
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Basic information
Public title
A Comparative study of the efficacy of Glidescope versus Macintosh direct laryngoscopy for intubation in pediatric patients undergoing cardiac surgery
Acronym
efficacy of Glidescope versus Macintosh direct laryngoscopy for intubation in pediatric patients
Scientific Title
A Comparative study of the efficacy of Glidescope versus Macintosh direct laryngoscopy for intubation in pediatric patients undergoing cardiac surgery
Scientific Title:Acronym
efficacy of Glidescope versus Macintosh direct laryngoscopy for intubation in pediatric patients
Region
| Asia(except Japan) |
Condition
Condition
pediatric patients undergoing cardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparing different intubation modalities should be done to assess its various outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
compare the efficacy of the Glidescope (video-laryngoscope) against the Macintosh direct laryngoscope
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The anesthetic techniques were standardized; patients were premedicated via oral midazolam 0.5 mg/kg IV. Induction of anesthesia was done via Ketamine 1.5- 2.5mg/kg IV, Fentanyl 2-10 ug/kg. Endotracheal intubation was performed using Rocuronium as a muscle relaxant with a dose of 0.5 mg/kg IV. Intubation was conducted by one operator only, to exclude variation in intubation skills, and the choice of the intubation device was dependent on the randomization program.
Interventions/Control_2
The second operator was responsible for monitoring the time taken for intubation in seconds, the incidence of desaturation, incidence of airway injury, the ease of intubation, and recording the data in the excel spreadsheet alongside the patient medical number and name.
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
| 1 | months-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- patients undergoing cardiac surgery for the repair of congenital heart disease.
- The patient's body weight had to be within the range of 3 to 30 kg
Key exclusion criteria
suspected difficult intubation, preterm babies with low body weight, and patients at risk of aspiration were all excluded
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ibrahim |
| Middle name | |
| Last name | Zabani |
Organization
King Faisal Specialist Hospital & Research Center
Division name
Anesthesiology
Zip code
23433
Address
Prince Saud Al Faisal, Ar Rawdah, Jeddah
TEL
00966504654717
izabani@gmail.com
Public contact
Name of contact person
| 1st name | Ibrahim |
| Middle name | |
| Last name | Zabani |
Organization
King Faisal Specialist Hospital & Research Center
Division name
Anesthesiology
Zip code
23433
Address
Prince Saud Al Faisal, Ar Rawdah, Jeddah
TEL
00966504654717
Homepage URL
izabani@gmail.com
Sponsor or person
Institute
King Faisal Specialist Hospital & Research Center
Institute
Department
Personal name
Funding Source
Organization
King Faisal Specialist Hospital & Research Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
King Faisal Specialist Hospital & Research Center
Address
Prince Saud Al Faisal, Ar Rawdah, Jeddah
Tel
+966 50 465 4717
IZabani@kfshrc.edu.sa
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
| 2021 | Year | 06 | Month | 22 | 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
50
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050808
