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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05018468
Other study ID # IR.MUI.REC.1395.3.424
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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