Clinical Trials Logo
  1. Home
  2. Intubation Complication
  3. NCT05018468
  4. Details
NCT05018468 Clinical Trial

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

Intubation Complication Clinical Trial

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

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

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05717907 - Suction Catheter as a Guide for Nasotracheal Intubation Under General Anesthesia N/A
Completed NCT03653910 - Effect-site Concentration of Remifentanil for Double-lumen Tubes Intubation: Airtraq VS Macintosh Laryngoscope N/A
Recruiting NCT04190524 - Sonographic Assessment of Cricoid Pressure N/A
Completed NCT02359370 - The Effects of Lidocaine and Magnesium Sulphate on the Attenuation of the Hemodynamic Response to Tracheal Intubation Phase 4
Not yet recruiting NCT05036460 - Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients N/A
Completed NCT05502120 - A Comparison of Vie-Scope and Macintosh Blade Laryngoscopes in Morbidly Obese. N/A
Completed NCT03992950 - Effectiveness of Cricoid and Paratracheal Pressures for Occluding Esophagus N/A
Completed NCT05303948 - Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness N/A
Completed NCT03720093 - Exploratory Analysis of Pulmonary Microbiome in Intubated Patients
Recruiting NCT03031808 - Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics Phase 4
Not yet recruiting NCT02918526 - Hemodynamic Study With PRAM of the Cardiovascular Response to the Positioning of the Extraglottic Device N/A
Completed NCT02364622 - The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube N/A
Completed NCT05249738 - Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients
Terminated NCT03340207 - Novel Airway Device to Aid Endotracheal Intubations N/A
Completed NCT03842306 - End-tidal Oxygen Can Reliably Predict the Arterial Partial Pressure of Oxygen Among Emergency Department Patients
Recruiting NCT05782517 - I-gel vs. Endotracheal Intubation for Laparoscopic Gynaecological Procedures N/A
Recruiting NCT06085326 - Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU- Multicenter Study N/A
Active, not recruiting NCT06108271 - Innovative Endotracheal Tube Design Reduces Postoperative Laryngeal Injury N/A
Completed NCT05668299 - Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush) N/A
Completed NCT04079387 - Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone N/A