CompletedNot Applicable

The Two-handed Mask Ventilation Study

Indonesia120 participantsStarted 2025-09-16

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 to 65 years old * ASA physical status 1 to 3 * Body mass index less than 30 kg/m square * Able to lie supine * Agree and signed infprmed consent * Induction is performed by intermediate or senior level of Anesthesia Resident Exclusion Criteria: * Predicted difficult ventilation * Patient with hypoxia (oxygen saturation less than 95%) * Predicted abnormal carbon dioxide * Acute or chronic lung disease * Plan to do rapid sequence induction * Plan to do awake intubation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ventilation effectiveness

Timeframe: During anesthesia induction

Trial details

NCT IDNCT07735845

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-14

View on ClinicalTrials.gov More Airway Anesthesia trials