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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018468
• Other study ID #: IR.MUI.REC.1395.3.424
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 20, 2021

Study information

• Verified date: August 2021
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 20, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Complication
• Intubation; Difficult or Failed
• Ventilation

Intervention

Device:
• Ventilation
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average airway pressure	Ventilation device	change from baseline at five minutes after incubation
Primary	Average End-tidal CO2 (EtCO2)	Ventilation device	change from baseline at five minutes after incubation
Primary	Average Oxygen saturation (SpO2)	Ventilation device	change from baseline at five minutes after incubation