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OpenTrials
Completed

NCT Number: NCT07735845

The Two-handed Mask Ventilation Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V-E two handed mask ventilation technique

Procedure

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.

C-E two handed mask ventilation technique

Procedure

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.

Primary outcomes

  1. Ventilation effectiveness

    Time frame: During anesthesia induction

    Ventilation is defined as effective when all of the following criteria are met : expired tidal volume of 4-6 mL/kg of body weight, measured end-tidal carbon dioxide within normal value and normal capnography waveform, and without desaturation (over 95%)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

A Comparative Study of V-E and C-E Two-handed Mask Ventilation Techniques in Adults Under General Anesthesia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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