UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025955 |
|---|---|
| Receipt number | R000029833 |
| Scientific Title | A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2019/04/11 14:14:09 |
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Basic information
Public title
A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Acronym
A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Scientific Title
A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Scientific Title:Acronym
A study of difficult tracheal intubations using McGRATH-MAC in patients undergoing elective surgeries
Region
| Japan |
Condition
Condition
Elective surgeries under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate failure rates of the first tracheal intubation for elective surgeries using McGRATH-MAC in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Failure rates of the first tracheal intubation performed by anethesiologists using McGRATH-MAC
Key secondary outcomes
Factors related to the first tracheal intubation failure
Management for the tracheal intubation failure
Complications with the tracheal intubation
Failure rates of the first tracheal intubation performed by non-anesthesiologists
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
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing elective surgeries and orotracheal intubation performed by anesthesiologists or non-anethesiologists supervised by anesthesiologists
Key exclusion criteria
Patients younger than 20 years-old
Patients undergoing awake intubation
Patients undergoing slow induction or rapid sequence induction
Patients undergoing tracheotomy
Patients who have already received tracheotomy
Patients undergoing tracheal intubation without neuromuscular blocking agents
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Namekawa |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
TEL
086-422-0210
mn14383@kctnet.or.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Namekawa |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
TEL
086-422-0210
Homepage URL
mn14383@kctnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurashiki Clinical Research Institute
Address
1-1-1 Miwa, Kurashiki, Okayama, 710-8602 Japan
Tel
086-422-0210
igakuken@kchnet.or.jp
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
| 2017 | Year | 02 | Month | 01 | 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
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
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single center, prospective, observational study
Research period: From February 1, 2017 to February 28, 2019
Estimated number of cases: 3,000 cases
Estimation of a sample size: We estimated failure rates of 1% for the first intubation. We calculated 3,000 cases as a sample size based on 95% confident interval of 1%.
Key inclusion criteria:
All patients undergoing elective surgeries and orotracheal intubation performed by anesthesiologists or non-anethesiologists supervised by anesthesiologists
Key exclusion criteria:
Patients younger than 20 years-old
Patients undergoing awake intubation
Patients undergoing slow induction or rapid sequence induction
Patients undergoing tracheotomy
Patients who have already received tracheotomy
Patients undergoing tracheal intubation without neuromuscular blocking agents
Measurements:
Age, Sex, Height, Weight, Primary disease, Department, Type of operation, Type of anesthesia, ASA class, Operation time, Anesthesia time
Denture use, Upset teeth, Protector of teeth, Snoring, Sleep apnea syndrome, Length of mouth opening, Mallampati class, Upper lip bite class, Neck perimeter, Thyromental distance, Sternomental distance, Limitation of neck extension, Cervical disease, Anatomical abnormalities in the neck
Length of mouth opening after neuromuscular block, Difficulty in mask ventilation, Cricoid pressure during tracheal intubation, Positioning of neck, Number of intubation attempt, Cause of intubation failure, Management for intubation failure, Operator of intubation, Cormack grade, Tube size, Tube type, Stylet, McGRATH-MAC blade size, Reason for use of other devices
Desaturation (SpO2<90%), Hypertension (systolic blood pressure>180mmHg), and Tachycardia (heart rate>130/min) during intubation period, Esophageal intubation, Aspiration, Injuries of lip, pharynx, trachea, and teeth, Steroid administration for laryngeal edema, Re-intubation for airway stenosis or edema
Management information
Registered date
| 2017 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029833
| Research Plan | |
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| Research case data specifications | |
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| Research case data | |
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