UMIN-CTR Clinical Trial

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
Email	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
Email	higuti@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Dental Anesthesiology and Special Care Dentistry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025924