Comparison of Two Types of Face Mask Ventilation in Obese Patients

NCT ID: NCT06219460

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-01

Brief 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.

Detailed 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.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cuffed face amsk

Ventilation using cuffed face mask

Group Type: EXPERIMENTAL

Ventilation using two types of face masks

Intervention Type: OTHER

ventilation using two types of face mask

Uncuffed face mask

Ventilation using uncuffed face mask

Group Type: EXPERIMENTAL

Ventilation using two types of face masks

Intervention Type: OTHER

ventilation using two types of face mask

Interventions

Ventilation using two types of face masks

ventilation using two types of face mask

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• obesity
• scheduled for elective surgery under general anesthesia

Exclusion Criteria

• predicted difficult intubation
• predicted difficult face-mask ventilation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Gaszynski

prof. dr hab.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Gaszynski, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz, Poland

Locations

Medical University of Lodz, Poland

Lodz, , Poland

Countries

Poland

Other Identifiers

RNN/96/13/KB

Identifier Type: -

Identifier Source: org_study_id