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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048470 |
Receipt No. | R000055241 |
Scientific Title | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/27 |
Basic information | ||
Public title | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. | |
Acronym | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. | |
Scientific Title | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. | |
Scientific Title:Acronym | Efficacy of proximal bending of an intubating stylet at indirect tracheal intubation using a McGRATH videolaryngoscope. | |
Region |
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Condition | ||
Condition | Tracheal intubation | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to investigate that using the stylet with the proximal bended 45 degrees forward facilitates intubation compared to using the stylet with the proximal bended 45 degrees to the right under using a McGRATH videolaryngoscope. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | Time for endotracheal tube induction |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Dose comparison |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Pseudo-randomization |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees forward. | ||
Interventions/Control_2 | Stylet with distal bended 60 degrees forward and the proximal bended 45 degrees to the right. | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients undergoing general anesthesia by tracheal intubation | |||
Key exclusion criteria | Ptients with anticipated ventilator or intubation difficulties
Patients with serious cerebrovascular disease, ischemic heart disease, or respiratory failure Isolated pulmonary ventilation case Awake intubation by bronchoscope Naso-tracheal intubation Tracheostomy patient |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | JCHO Chukyo Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 457-8510 | ||||||
Address | 1-1-10, Sanjou, Minami, Nagoya, Aichi | ||||||
TEL | 052-691-7151 | ||||||
tai_1_lan@icloud.com |
Public contact | |||||||
Name of contact person |
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Organization | JCHO Chukyo Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 457-8510 | ||||||
Address | 1-1-10, Sanjou, Minami, Nagoya, Aichi | ||||||
TEL | 052-691-7151 | ||||||
Homepage URL | |||||||
tai_1_lan@icloud.com |
Sponsor | |
Institute | JCHO Chukyo Hospital
Department of Anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | None |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Ethical review board of JCHO Chukyo hospital |
Address | 1-1-10, Sanjou, Minami, Nagoya, Aichi |
Tel | 052-691-7151 |
tai_1_lan@icloud.com |
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 | JCHO中京病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055241 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |