UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022499 |
|---|---|
| Receipt number | R000025924 |
| Scientific Title | The study for the utility of Nasal High flow system during dental sedation in obesity patients with intellectual disability |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2021/08/10 19:02:26 |
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Basic information
Public title
The study for the utility of Nasal High flow system during dental sedation in obesity patients with intellectual disability
Acronym
The utility of Nasal High flow system during dental sedation
Scientific Title
The study for the utility of Nasal High flow system during dental sedation in obesity patients with intellectual disability
Scientific Title:Acronym
The utility of Nasal High flow system during dental sedation
Region
| Japan |
Condition
Condition
Dental diseases
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intravenous sedation is very useful for dental treatment of patients with intellectual disability. However, we are forced to manage them with deep sedation because their cooperation cannot be obtained. In deep sedation, airway management aimed at maintaining the patient's oxygen levels is important for patient safety. In some patients with intellectual disability, obesity is accompanied because self-dietary control is sometime difficult. These obese patients are more likely to suffer airway blockages and reductions in arterial oxygen saturation (SpO2) than non-obese patients. Therefore, airway obstruction and hypoxia are major incidents that anesthetists often encounter in obese patients.
Nasal high-flow systems (NHFS) are a new type of device that can supply warmed and humidified oxygen at a high flow rate. In a recent study, the use of a NHFS resulted in the better outcome for oxygen therapy in intensive care. Therefore, we hypothesized that the use of NHFS during dental sedation might significantly prevent hypoxia in obese patients. In this crossover study, we will investigate whether NHFS use can improve oxygenation in obese patients during dental sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Minimum arterial oxygen saturation (SAT) during sedation.
Key secondary outcomes
1. The frequency and duration of SAT<=94% during sedation.
2. The frequency and duration of SAT<=90% during sedation.
3. Arterial oxygen pressure and arterial carbon dioxide pressure
4. Assisted ventilation with a bag valve mask
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The use of Optiflow
Interventions/Control_2
Oxygen administration by normal nasal cannula
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. Being aged >= 16 years
2. Exhibiting an ASA physical state of 1 or 2
3. Body Mass Index (BMI) >= 25
4. Suffering from a severe intellectual disability and not cooperating fully with dental treatment
Key exclusion criteria
1. Exhibiting an ASA physical state of >3
2. Being contraindicated for the use of midazolam or propofol.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
7008525
Address
2-5-1 Shikata-cho Kita-ku, Okayama, Japan
TEL
086-235-6721
higuti@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Hitoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
7008525
Address
2-5-1 Shikata-cho Kita-ku, Okayama, Japan
TEL
086-235-6721
Homepage URL
higuti@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Dental Anesthesiology and Special Care Dentistry
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Dental Anesthesiology and Special Care Dentistry
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatacho Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.joms.2021.04.004
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.joms.2021.04.004
Number of participants that the trial has enrolled
18
Results
The mean minimum arterial oxygen saturation (SpO2) value was significantly higher in the NHFS arm than in the control arm (95.8 (2.1) % vs. 93.6 (4.1) %). Hypoxemic episodes (SpO2: 94% or less) occurred 3 cases (16.7%) in the NHFS arm and 11 case (61.1%) in the control arm (P=0.0076).
Results date posted
| 2021 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 07 | Day |
Baseline Characteristics
Obese patients (body mass index: 25 or higher) with intellectual disabilities who underwent dental sedation
Participant flow
The subjects were randomly assigned to the control oxygen administration (5 L/min via a nasal cannula) or NHFS (40% O2, 40 L/min, 37 degrees Celsius) arm in alternate shifts as a crossover trial.
Adverse events
None
Outcome measures
Minimum SpO2 value
Incidence rates of hypoxemia(SpO2: 94% or less)
Incidence rates of severe hypoxemia(SpO2: 90% or less)
Partial pressure of arterial O2 (PaO2)
Partial pressure of arterial CO2 (PaCO2)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025924
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