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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05018468

Enrollment

Registered

2021-08-24

Start date

2021-01-01

Completion date

2021-06-20

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication, Intubation; Difficult or Failed, Ventilation

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.

Interventions

DEVICEVentilation

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
Average Oxygen saturation (SpO2)	change from baseline at five minutes after incubation	Ventilation device

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026