UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000035550 |
| Receipt No. | R000040496 |
| Scientific Title | Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/11/02 (Ver. 4) |
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| Basic information | ||
| Public title | Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist | |
| Acronym | The effectiveness of the McGRATH MAC | |
| Scientific Title | Comparison of success rate of tracheal intubation with Macintosh laryngoscope and McGRATH MAC by resident and anesthesiologist | |
| Scientific Title:Acronym | The effectiveness of the McGRATH MAC | |
| Region |
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| Condition | ||
| Condition | Patients undergoing general anesthesia by tracheal intubation | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | Evaluating the success rate of tracheal intubation when the resident and anesthesiologist use Macintosh laryngoscope and McGRATH MAC |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | The success rate of tracheal intubation |
| Key secondary outcomes | |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
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| Interventions/Control_3 | |
| Interventions/Control_4 | |
| Interventions/Control_5 | |
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| 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 | Emergency operation
Open heart surgery Isolated pulmonary ventilation case Laryngeal mask case Pregnant women Awake intubation by bronchoscope Naso-tracheal intubation Tracheostomy patient |
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| Target sample size | 30 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Okazaki city hospital | ||||||
| Division name | Department of Anesthesiology | ||||||
| Zip code | 444-8553 | ||||||
| Address | 3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan | ||||||
| TEL | 0564-21-8111 | ||||||
| oniheizo1745@gmail.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Okazaki city hospital | ||||||
| Division name | Department of Anesthesiology | ||||||
| Zip code | 444-8553 | ||||||
| Address | 3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan | ||||||
| TEL | 0564-21-8111 | ||||||
| Homepage URL | |||||||
| oniheizo1745@gmail.com | |||||||
| Sponsor | |
| Institute | Okazaki city hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Okazaki city hospital |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Okazaki city hospital |
| Address | 3-1 Goshoai, Kouryuji-cho, Okazaki-city, Aichi 444-8553, Japan |
| Tel | 0564-21-8111 |
| oniheizo1745@gmail.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 | 岡崎市民病院（愛知県） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | |||||||
| Number of participants that the trial has enrolled | 110 | ||||||
| Results | The success rate of tracheal intubation Medical intern success rate with laryngoscope 80.4% success rate with McGrath MAC 100% Anesthesiologist success rate with laryngoscope 85.9% success rate with McGrath MAC 100% No adverse event |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results |
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| Baseline Characteristics | |||||||
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| Outcome measures | |||||||
| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| 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 trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | Preoperative predictor of difficult airway |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040496 |
