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NCT Number: NCT05018468

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

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.

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Key information

Conditions

Ventilation Intubation Complication Intubation; Difficult or Failed Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alzahra Hospital

Isfahan, 8195163381, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ventilation

Device

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

Primary outcomes

  1. Average airway pressure

    Time frame: change from baseline at five minutes after incubation

    Ventilation device

  2. Average End-tidal CO2 (EtCO2)

    Time frame: change from baseline at five minutes after incubation

    Ventilation device

  3. Average Oxygen saturation (SpO2)

    Time frame: change from baseline at five minutes after incubation

    Ventilation device

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 24, 2021
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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