Comparison of Oxygenation Methods in Sedation

Not Applicable

• Conditions: Deep Sedation
• Interventions: Device: nasal mask; Device: nasal cannula

• Registration Number: NCT03893877
• Lead Sponsor: TC Erciyes University

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.

Study Timeline

• Study Start: 2018-11-04
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Status Verified: 2020-03
• Primary Completion: 2020-03-01
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nasal mask	nasal mask	device:nasal mask will be applied to patients for oxygenation under deep sedation
nasal cannula	nasal cannula	device:nasal cannula will be applied to patients for oxygenation under deep sedation

Primary Outcome Measures

Name	Time	Method
effects of non invasive mechanical ventilation on oxygen saturation during deep-sedated patients.	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.

Trial Locations

Locations (1)

Seher Orbay Yasli; 🇹🇷 Kayseri, Turkey