Comparison of Oxygenation Methods in Sedation

Deep Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03893877
• Other study ID #: 2018/475
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: March 2020
• Source: TC Erciyes University
• Contact: Seher O Yasli
• Phone: 03522076666
• Email: sehersin81[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation

Intervention

Device:
• nasal cannula
experimental group will be applied nasal cannula
• nasal mask
active comparator group will be applied nasal mask

Locations

Country	Name	City	State
Turkey	Seher Orbay Yasli	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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