- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893877
Comparison of Oxygenation Methods in Sedation
Noninvasive Mechanic Ventilation With Nasal Mask is Better Than Oxygen Delivery Via Nasal Cannula for Dental Treatments in Children Performed Under Deep Sedation: Randomised ,Prospective, Clinical Study
Abstract
Backgrounds and objectives:
Dental treatments, especially in children who can not be cooperated, may require deep sedation due to intense anxiety and fear. During sedation oxygen is usually given to the patients by nasal cannula. Investigators want to use nasal mask for non-invasive mechanical ventilation for oxygenation of the patient during sedation for dental treatment and described it with nasal cannula.
Methods:
Seventy three children classified as ASA 1 or 2, aged between 3 to 17 will be included for this study. During deep sedation procedure group M will be applied nasal mask in order to noninvazive mechanical ventilation, group C will be applied nasal cannula connected to the oxygen flowmeter.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Majority of dental treatments can be performed under local anesthesia. However, this is not always possible for pediatric non-cooperative patients with severe anxiety. In these cases, unpleasant dental experiences may lead to dental phobia when they become adults. For such patients requiring short-term dental procedures, sedation can best choice.
In sedative procedures of patients it is necessary to delivery oxygen to the patient's respiratory system. This can achieved by means of nasal cannulas or interface masks like nasal mask which are connected to the oxygen flowmeter of the anesthesia machine. Investigators hypotezed that oxygen delivery via non-invazive machanic ventilation with nasal mask which is connected to the anesthesia-breathing circuit unit could be better than nasal cannula connected to the oxygen flowmeter of the anesthesia machine during deep sedation for dental treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seher O Yasli
- Phone Number: 03522076666
- Email: sehersin81@hotmail.com
Study Locations
-
-
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Kayseri, Turkey, 38039
- Recruiting
- Seher Orbay Yasli
-
Contact:
- Seher O Yasli
- Phone Number: 5052401933
- Email: sehersin81@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients aged betweeen 3-17
- patients with wn ASA( American Society of Anesthesiologists) score 1-2
Exclusion Criteria:
- patients under 3 years old
- patients above of ASA score 2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nasal cannula
device:nasal cannula will be applied to patients for oxygenation under deep sedation
|
experimental group will be applied nasal cannula
|
Active Comparator: nasal mask
device:nasal mask will be applied to patients for oxygenation under deep sedation
|
active comparator group will be applied nasal mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effects of non invasive mechanical ventilation on oxygen saturation during deep-sedated patients.
Time Frame: 30 MINUTES
|
In investigators want to discuss the differences of oxygen saturations between nasal cannula and nasal mask.sedative
procedures of patients it is necessary to delivery oxygen to the patient's respiratory system.
This can achieved by means of nasal cannulas or interface masks like nasal mask which are connected to the oxygen flowmeter of the anesthesia machine.
|
30 MINUTES
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seher O Yasli, Ercıyes University faculty of dentistry
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018/475
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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