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
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2018
CompletedFirst Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMarch 12, 2020
March 1, 2020
1.3 years
November 6, 2018
March 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
effects of non invasive mechanical ventilation on oxygen saturation during deep-sedated patients.
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
Study Arms (2)
nasal cannula
EXPERIMENTALdevice:nasal cannula will be applied to patients for oxygenation under deep sedation
nasal mask
ACTIVE COMPARATORdevice:nasal mask will be applied to patients for oxygenation under deep sedation
Interventions
Eligibility Criteria
You may qualify if:
- patients aged betweeen 3-17
- patients with wn ASA( American Society of Anesthesiologists) score 1-2
You may not qualify if:
- patients under 3 years old
- patients above of ASA score 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seher Orbay Yasli
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seher O Yasli
Ercıyes University faculty of dentistry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
November 6, 2018
First Posted
March 28, 2019
Study Start
November 4, 2018
Primary Completion
March 1, 2020
Study Completion
May 1, 2020
Last Updated
March 12, 2020
Record last verified: 2020-03