The Two-handed Mask Ventilation Study
NCT07735845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-07-30
Summary
The goal of this clinical trial is to find out which two-handed face mask ventilation technique is the most effective in delivering oxygen to adult patients with Body Mass Index (BMI) less than 30 kg/m2, able to lie supine, have ASA physical status of 1-3, and are scheduled to undergo elective procedures under general anesthesia.
The main question it aims to answer is:
• Which type of two-handed mask-holding technique is the most effective in providing oxygen to the patient?
Researchers will compare one randomized hand technique to another randomized hand technique to see if one is more effective than the other at delivering oxygen to the patient before a breathing tube is inserted.
Participants will:
* Complete an assessment during a pre-anesthesia visit in the inpatient ward
* Undergo baseline measurements of blood pressure, heart rate, and peripheral oxygen saturation in the operating room on the day of surgery.
* Lie supine and receive 100% oxygen via a face mask.
* Receive general anesthetic drugs then breathing assistance will be delivered with a face mask connected to a ventilator machine using one of the randomly assigned two hand-holding techniques.
* Undergo standard placement of a breathing tube to continue their scheduled surgery.
Conditions
- Airway Anesthesia
- Ventilation, Mechanical
Interventions
- PROCEDURE
-
V-E two handed mask ventilation technique
In the V-E technique, the thumb of each hand is placed on the superolateral sides of the face mask to apply downward (caudal) pressure, while the remaining four fingers form an "E" shape and are positioned at the mandibular angles to elevate the mandible.
- PROCEDURE
-
C-E two handed mask ventilation technique
In the C-E technique, the thumb and index finger of each hand form a "C" shape on both superior sides of the face mask to apply pressure, while the remaining three fingers form an "E" shape to elevate the mandible.
Sponsors & Collaborators
-
Indonesia University
lead OTHER
Principal Investigators
-
Anas Alatas, Cardiovascular Anesthetist · Fakultas Kedokteran Universitas Indonesia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-16
- Primary Completion
- 2026-04-14
- Completion
- 2026-04-14
Countries
- Indonesia
Study Locations
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