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Efficacy of C-airway in mask ventilation of edentulous patients undergoing general anesthesia: A clinical trial study

Efficacy of C-airway in mask ventilation of edentulous patients undergoing general anesthesia: A clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230309057661N1
Enrollment
60
Registered
2023-03-18
Start date
2023-04-21
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C-airway in mask ventilation of edentulous patients. Failed or difficult intubation

Interventions

Intervention 1: Intervention group: Group A are patients who are ventilated with a mask using C-Airway
With the explanation that after removing the artificial tooth, the C-Airway with the right size is selected and placed in such a way that it fills both buccal spaces. Intervention 2: Control group: Gr
With the explanation that after removing the denture, a standard airway with the appropriate size is used for ventilation with a mask.

Sponsors

Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria for the study are based on the fact that the patients are selected in such a way that they are homogeneous with each other in terms of sex, age, weight distribution and classification based on the classification of the clinical condition of the American Society of Anesthesiologists (ASA) and are in category 1 to 3. None of the patients have BMI greater than 30, gastric tube, facial structural abnormality, and long beard and mustache. Also, none of the patients have a history of snoring and according to Malampathi's classification, they are in group 1 and 2.

Exclusion criteria

Exclusion criteria: The exclusion criterion is based on the fact that if the disease is considered a medical emergency, it will not be included in this study.

Design outcomes

Primary

MeasureTime frame
Adequate mask ventilation is the main variable measured in this research. Adequate mask ventilation defined as increasing ETCO2 to 35-45 mm Hg and returning to baseline if the total fresh gas flow to the anesthesia machine is set to 3 Lit/min and the pressure regulating valve is set to 20 cm H2O. Timepoint: It is continuously monitored and recorded for 3 minutes. Method of measurement: Measuring of CO2 concentration in each exhalation by capnograph.

Secondary

MeasureTime frame
1. Air leakage, which is defined as a difference of more than 33% in the volume of air flowing in inhalation and exhalation. 2. Difficult mask ventilation, which is defined as not stabilizing the oxygen saturation percentage in values ??above 92% in the case of mask ventilation with 100% oxygen. Timepoint: It is continuously monitored and measured for 3 minutes. Method of measurement: The amount of air leakage is measured by anesthesia machine and the percentage of oxygen saturation is measured by pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbolfazl Mazhari

Semnan University of Medical Sciences

parsa.mazhary@gmail.com+98 23 3343 0797

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026