UMIN-CTR Clinical Trial

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
Email	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
Email	izabani@gmail.com

Sponsor
Institute	King Faisal Specialist Hospital & Research Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050808