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

NCT05018468 | Completed

• 1 other identifier: IR.MUI.REC.1395.3.424
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation; Intubation Complication; Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (3)

• Average airway pressure

  Ventilation device

  change from baseline at five minutes after incubation

• Average End-tidal CO2 (EtCO2)

  Ventilation device

  change from baseline at five minutes after incubation

• Average Oxygen saturation (SpO2)

  Ventilation device

  change from baseline at five minutes after incubation

Study Arms (2)

ventilation with an anatomical facial mask

EXPERIMENTAL

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

ventilation with a nasal mask

EXPERIMENTAL

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

Interventions

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.

Also known as: Mask

ventilation with a nasal mask; ventilation with an anatomical facial mask

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Impossibility of airway oropharyngeal ventilation
• Impossibility of ventilation of the anatomical facial mask with neck extension
• Dissatisfaction with participating in the study.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra Hospital

Isfahan, 8195163381, Iran

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: June 20, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IR (1)