Quality of Ventilation With Facial Versus Nasal Mask vs Nasal Mask Anesthesia in Children 3 to 12 Years Old

Study Overview
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Brief Summary
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In this single-blind clinical trial study, 70children who are candidates for lower abdominal elective surgery under general anesthesia presented at Imam Hossein Hospital in Isfahan will be included in the study and will be divided into 2 groups. In the first group, ventilation with facial mask and in the second group, ventilation with nasal mask will be done for three minutes. Then the reduction in SPO2 and the impossibility of ventilation of patients will be evaluated and compared between the two groups.

Official Title
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Evaluation of the Quality of Ventilation With Facial Versus Nasal Mask After Induction of Anesthesia in Children 3 to 12 Years Old

Conditions
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Ventilation, Intubation Complication, Intubation; Difficult or Failed

Intervention / Treatment
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* Device: Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age category between 3 to 12 years Candidate for lower abdominal elective surgery under general anesthesia No obstruction in the nasal pathway No deformity and fractures in facial No acute or chronic lung disease Exclusion Criteria: Impossibility of airway oropharyngeal ventilation Impossibility of ventilation of the anatomical facial mask with neck extension Dissatisfaction with participating in the study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ventilation with an anatomical facial mask<br>Intervention group 1: Patients in this group undergo ventilation with an anatomical facial mask and 100% oxygen for three minutes. Intervention group 2: Patients in this group undergo ventilation with a nasal mask and 100% oxygen for three minutes. In both groups, ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min. | Device: Ventilation<br>* Patients in group 1 undergo ventilation with an anatomical facial mask and 100% oxygen for three minutes. Patients in group 2 undergo ventilation with a nasal mask and 100% oxygen for three minutes. In both groups, ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min.<br>* Other names: Mask;|
| Experimental: ventilation with a nasal mask<br>Intervention group 2: Patients in this group undergo ventilation with a nasal mask and 100% oxygen for three minutes. Ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min. | Device: Ventilation<br>* Patients in group 1 undergo ventilation with an anatomical facial mask and 100% oxygen for three minutes. Patients in group 2 undergo ventilation with a nasal mask and 100% oxygen for three minutes. In both groups, ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min.<br>* Other names: Mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average airway pressure | Ventilation device | change from baseline at five minutes after incubation | 
| Average End-tidal CO2 (EtCO2) | Ventilation device | change from baseline at five minutes after incubation | 
| Average Oxygen saturation (SpO2) | Ventilation device | change from baseline at five minutes after incubation |