Protocol summary
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Study aim
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Comparison of direct laryngoscopy with video laryngoscopy in pediatric airway management for Congenital Heart surgery
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Design
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This clinical trial will be performed on 60 children aged 1 to 5 years with anesthesia class1 to 3 who will be candidates for tracheal intubation for elective congenital cardiac surgery. After the necessary monitoring was performed, pulse oximetry, electrocardiography, non-invasive pressure and anesthesia were performed by an anesthetist by a constant method (including fentanyl 20 micrograms per kilogram and atracurium 5 / mg / kg) randomly In one group (direct laryngoscopy or laryngoscopy by video laryngoscopy ). The
The choice of patient for intubation by video laryngoscope or direct laryngoscope is one way. The input view and the intubation time will be recorded in each group.
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Settings and conduct
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This study will be done in the open heart surgery room of Golestan Hospital
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:1- Children aged 1 to 5 years 2- Elective congenital cardiac surgery 3- Class anesthesia 1 to 3
Exclusion criteria:There are difficult airway
2. There are risk of pulmonary aspiration.
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Intervention groups
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In group 1 , tracheal intubation with direct layngoscopy will be done.
In group 2, tracheal intubation with video layngoscopy will be done.
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Main outcome variables
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the primary outcome is:the number of success rate in the first attempt to intubation, and the secondary outcomes are: including the duration of successful intubation and the number of intubation failures in the first attempt
General information
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Reason for update
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This project was conducted as double-blind
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180909040979N2
Registration date:
2019-03-18, 1397/12/27
Registration timing:
prospective
Last update:
2020-04-08, 1399/01/20
Update count:
1
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Registration date
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2019-03-18, 1397/12/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-21, 1398/01/01
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Expected recruitment end date
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2019-08-23, 1398/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of direct laryngoscopy with video laryngoscopy in pediatric airways management for Congenital Heart surgery
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Public title
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Comparison of direct laryngoscopy with video laryngoscopy
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Anesthesia class 1-3
Candidate for tracheal intubation
Candidate for elective congenital cardiac surgery
Exclusion criteria:
There are difficult airway
There are at risk for pulmonary aspiration
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Age
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From 1 year old to 5 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Principal investigator and the patient is not aware of the type of intervention
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-04, 1397/12/13
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Ethics committee reference number
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IR.AJUMS.REC.1397.907
Health conditions studied
1
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Description of health condition studied
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Intubation
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ICD-10 code
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T88.4
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ICD-10 code description
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Failed or difficult intubation
Primary outcomes
1
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Description
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The success rate for intubation in first attempt
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Timepoint
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After intubation
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Method of measurement
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Capnograph
Secondary outcomes
1
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Description
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Success intubation time
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Timepoint
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After intubation
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Method of measurement
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Cronometer
2
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Description
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Failed intubation
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Timepoint
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After intubation
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Method of measurement
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Capnograph
Intervention groups
1
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Description
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Control group: In control group intubations are done using direct laryngoscopy in which rigid laryngoscope is used to expose the laryngeal inlet under direct vision to facilitate intubation.
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Category
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Prevention
2
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Description
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Intervention group: in intervention group intubations are done using video laryngoscope. Video laryngoscope utilizes video camera technology to visualize airway structures and facilitate endotracheal intubation.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available