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

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Ventilation; Intubation Complication
• Interventions: Device: Ventilation

• Registration Number: NCT05018468
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-20
• Status Verified: 2021-08
• Study First Submitted: 2021-08-01
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ventilation with an anatomical facial mask	Ventilation	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.
ventilation with a nasal mask	Ventilation	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.

Primary Outcome Measures

Name	Time	Method
Average Oxygen saturation (SpO2)	change from baseline at five minutes after incubation	Ventilation device
Average airway pressure	change from baseline at five minutes after incubation	Ventilation device
Average End-tidal CO2 (EtCO2)	change from baseline at five minutes after incubation	Ventilation device

Trial Locations

Locations (1)

Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of