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

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05018468
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
5.6
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ventilation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Evaluation of the Quality of Ventilation With Facial Versus Nasal Mask After Induction of Anesthesia in Children 3 to 12 Years Old
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Jun 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ventilation with an anatomical facial mask

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
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.
Other Names:
  • Mask

    		•
    Experimental: ventilation with a nasal mask

    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
    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.
    Other Names:
  • Mask

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average airway pressure [change from baseline at five minutes after incubation]

      Ventilation device

    2. Average End-tidal CO2 (EtCO2) [change from baseline at five minutes after incubation]

      Ventilation device

    3. Average Oxygen saturation (SpO2) [change from baseline at five minutes after incubation]

      Ventilation device

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alzahra Hospital Isfahan Iran, Islamic Republic of 8195163381

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amir Shafa, Director, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05018468
    Other Study ID Numbers:
    • IR.MUI.REC.1395.3.424
    First Posted:
    Aug 24, 2021
    Last Update Posted:
    Aug 24, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 24, 2021