End Tidal Carbon Dioxide in Minimal Sedation

Study Overview
=================
Brief Summary
-----------------
This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.

Official Title
-----------------
A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients

Conditions
-----------------
Complication of Anesthesia

Intervention / Treatment
-----------------
* Other: end tidal carbon dioxide monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing minimal sedation for procedure. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: end tidal carbon dioxide monitoring<br> | Other: end tidal carbon dioxide monitoring<br>* We will monitor end tidal carbon dioxide with capnography during minimal sedation<br>|
| No Intervention: Oxygen saturation monitoring<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of oxygen desaturation | oxygen saturation lower than 95% | from immediately after sedation to end of procedure, up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Staff intervetions | tactile stimulation, jaw thrust or head tilt, suction, oral or nasopharyngeal airway insertion, oxygen supply, laryngeal mask airway insertion, bag-valve mask ventilation, endotracheal intubation | from immediately after sedation to end of procedure, up to 2 hours | 
| Severe oxygen desaturation | oxygen saturation lower than 85%, 90% | from immediately after sedation to end of procedure, up to 2 hours | 
| Lowest oxygen saturation | value of oxygen saturation | from immediately after sedation to end of procedure, up to 2 hours | 
| Episode of apnea | capnography flat line more than 5 seconds | from immediately after sedation to end of procedure, up to 2 hours | 
| sedation level | 6-point pediatric sedation state scale | from immediately after sedation to end of procedure, up to 2 hours | 
| inappropriate monitoring | the duration of inappropriate capnography monitoring | from immediately after sedation to end of procedure, up to 2 hours | 
| Airway obstruction | stridor, retraction | from immediately after sedation to end of procedure, up to 2 hours | 
| Integrated pulmonary index | calculated parameter | from immediately after sedation to end of procedure, up to 2 hours | 
| success of procedure | success or fail of sedation or procedure | from immediately after sedation to end of procedure, up to 2 hours | 
| Hemodynamic instability | heart rate and blood pressure change more than 20% | from immediately after sedation to end of procedure, up to 2 hours | 
| Medication | type and dosage of sedatives | from immediately after sedation to end of procedure, up to 2 hours |