Comparison of Two Types of Face Mask Ventilation in Obese Patients

Obesity, Morbid Clinical Trial

Official title:

A Comparison of Two Types of Face Masks: Cuffed and Uncuffed for Ventilation of Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219460
• Other study ID #: RNN/96/13/KB
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.

Description:

The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.

The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• obesity

• scheduled for elective surgery under general anesthesia

Exclusion Criteria:

• predicted difficult intubation

• predicted difficult face-mask ventilation

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Other:
• Ventilation using two types of face masks
ventilation using two types of face mask

Locations

Country	Name	City	State
Poland	Medical University of Lodz, Poland	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sealing of face masks measured by difference of inspired tidal volume and expired volume	Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine	immediatethrough study completion