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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03893877
Enrollment
70
Registered
2019-03-28
Start date
2018-11-04
Completion date
2020-05-01
Last updated
2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sedation

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.

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.

Interventions

experimental group will be applied nasal cannula

active comparator group will be applied nasal mask

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
effects of non invasive mechanical ventilation on oxygen saturation during deep-sedated patients.30 MINUTESIn 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSeher O Yasli
sehersin81@hotmail.com03522076666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026