NCT07735845

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

July 25, 2026

Last Update Submit

July 25, 2026

Conditions

Airway AnesthesiaVentilation, Mechanical

Keywords

Mask ventilationV-E techniqueC-E techniqueGeneral anesthesiaTidal volume

Outcome Measures

Primary Outcomes (1)

  • Ventilation effectiveness

    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%)

    During anesthesia induction

Study Arms (2)

V-E group

EXPERIMENTAL
Procedure: V-E two handed mask ventilation technique

C-E group

ACTIVE COMPARATOR
Procedure: C-E two handed mask ventilation technique

Interventions

V-E two handed mask ventilation techniquePROCEDURE

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.

V-E group
C-E two handed mask ventilation techniquePROCEDURE

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.

C-E group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anas Alatas, Cardiovascular Anesthetist

    Fakultas Kedokteran Universitas Indonesia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr., Sp.An-TI, Subsp.An.Kv.(K)

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 30, 2026

Study Start

September 16, 2025

Primary Completion

April 14, 2026

Study Completion

April 14, 2026

Last Updated

July 30, 2026

Record last verified: 2026-06

Locations

ID(1)