Airway AnesthesiaNCT07735845
The Two-handed Mask Ventilation Study
A study testing V-E two handed mask ventilation technique and C-E two handed mask ventilation technique in people with Airway Anesthesia and Ventilation, Mechanical, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Anesthesia, Ventilation, Mechanical
- What is being tested?
- V-E two handed mask ventilation technique and C-E two handed mask ventilation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Sep 2025to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: A Comparative Study of V-E and C-E Two-handed Mask Ventilation Techniques in Adults Under General Anesthesia
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:
Read more
- 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
- Being tested
- V-E two handed mask ventilation technique, C-E two handed mask ventilation technique
- Keywords
- Mask ventilation, V-E technique, C-E technique, General anesthesia, Tidal volume
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-E two handed mask ventilation techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| V-E group | Experimental | Not described Receives: Procedure: V-E two handed mask ventilation technique |
| C-E group | Active comparator | Not described Receives: Procedure: C-E two handed mask ventilation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: During anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start16 Sep 2025
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anas Alatas, Universitas Indonesia
- Investigators
- Anas Alatas, Cardiovascular Anesthetist, Study director, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735845
- Sponsor's protocol ID
- 25-07-0975
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of V-E and C-E Two-handed Mask Ventilation Techniques in Adults Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07735845
- Acronym / sponsor ID
- 25-07-0975
- Conditions
- Airway Anesthesia, Ventilation, Mechanical
- Keywords
- Mask ventilation, V-E technique, C-E technique, General anesthesia, Tidal volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-E two handed mask ventilation techniqueIn 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 or surgery | V-E group |
| C-E two handed mask ventilation techniqueIn 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. | Procedure or surgery | C-E group |
Primary outcome
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%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anas Alatas, Cardiovascular Anesthetist study director
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V-E two handed mask ventilation technique and C-E two handed mask ventilation technique in people with Airway Anesthesia and Ventilation, Mechanical, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation effectiveness (time frame: During anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.