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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011387
Receipt No. R000013181
Scientific Title A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Date of disclosure of the study information 2013/08/06
Last modified on 2017/11/14

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Basic information
Public title A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Acronym A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Scientific Title A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Scientific Title:Acronym A utility of capnography during dental sedation for patients with intellectual disability: A prospective randomized controlled study
Region
Japan

Condition
Condition Dental Problem
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to evaluate whether capnography prevents patient's hypoxia during dental sedation for patients with intellectual disability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient oxygen desaturation defined as a pulse oximetry reading of <= 95%
Key secondary outcomes 1) Patient oxygen desaturation defined as a pulse oximetry reading of <= 90%
2) Increasing total flow of oxygen
3) Artificial ventilation by bag valve mask

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
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
Device,equipment
Interventions/Control_1 In control group, observer gives the anesthesiologist advice to clear patient's airway when capnography show airway obstruction or apnea during 60s.
Interventions/Control_2 In intervention group, observer gives the anesthesiologist advice to clear patient's airway when capnography show airway obstruction or apnea during 15s.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age 16 years or older.
2) Severe intellectual disability, and not cooperating fully with dental treatment.
3) American Society of Anesthesiologists (ASA) physical status 1 or 2.
Key exclusion criteria 1) ASA physical status 3 or over.
2) Preoperative value of pulse oximetry is under 95%.
3) Body mass index (BMI) is over 30.
4) Contraindication to midazolam or propofol.
Target sample size 246

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Miyawaki
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama Japan
TEL 086-235-6721
Email miyawaki@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Higuchi
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama Japan
TEL 086-235-6721
Homepage URL
Email higuti@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 06 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
2013 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 06 Day
Last follow-up date
2015 Year 03 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
2013 Year 08 Month 06 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013181

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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