Skip to content

Effectiveness of Facial Mask NIV in Adults Under General Anesthesia: Two-Hand C-E vs V-E Techniques

Effectiveness of Facial Mask Non-Invasive Ventilation in Adults Under General Anesthesia: Two-Hand C-E vs V-E Techniques. A Double-Blind Randomized Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07179432
Acronym
VENTMASK
Enrollment
206
Registered
2025-09-17
Start date
2025-01-01
Completion date
2026-08-01
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthetics

Keywords

ventilation, mask ventilation

Brief summary

This study aims to compare two different ways doctors hold a face mask to help the participant breathe during general anesthesia. The investigators are evaluating which method, the C-E or the V-E technique, works best. If the participant chooses to take part, on the day of surgery, after anesthesia has been administered and the participant is asleep, the doctor will use one of these two mask-holding techniques to assist breathing for a short period. The investigators will measure how effectively the participant is breathing, check carbon dioxide levels, and record the doctors' assessment of how easy and comfortable each technique was for them. This study will not alter any other aspect of the surgery or recovery.

Detailed description

Airway management is a routine part of an anesthesiologist's work when subjecting patients to different degrees of sedation, eventually reaching general anesthesia. It is also crucial in emergency care, where general practitioners, emergency physicians, and prehospital care technicians/technologists (APH) manage the airway, each with varying degrees of training and experience. In these scenarios, the doctor or APH provider will determine whether to maintain the airway using invasive or non-invasive methods to achieve proper ventilation. Factors such as patient characteristics, which may predict difficult mask ventilation combined with difficult laryngoscopy, include: Mallampati classification III or IV, obesity (BMI over 30 kg/m²), presence of teeth, history of obstructive sleep apnea, short thyromental distance, limited mandibular protrusion, cervical mass, limited neck extension, presence of a beard, male gender, or age over 46 years. However, it has been observed that predictions about difficult mask ventilation or difficult intubation only correspond to actual difficult airway scenarios 25% of the time. Furthermore, difficult intubation and difficult mask ventilation were unanticipated in 93% and 94% of cases, respectively. Other factors that influence patient outcomes include the patient's current condition based on the context, such as elective surgery versus an emergency scenario. This can be the same patient at two different times, but the approach may vary depending on the physician's training and experience, whether it is an APH technician/technologist, a general practitioner, an emergency physician, or an anesthesiologist. These decisions are also influenced by the availability of equipment. Mask ventilation is often considered intuitive, but it has been demonstrated to be difficult to learn and apply in both hospital and prehospital settings . In such scenarios, the face mask should always be available and serves as the initial approach before invasive airway management or rescue if intubation or a supraglottic device fails. Therefore, proper training in face mask ventilation skills, including the two-hand technique, is necessary to improve the seal, mandibular protrusion, and neck extension, targeting the determinants of difficult mask ventilation as defined by the ASA: The inability to provide adequate ventilation (e.g., confirmed by detection of end-tidal carbon dioxide) due to any of the following: inadequate mask seal, excessive gas leak, or excessive resistance to gas entry or exit. For two-handed mask ventilation, two techniques have been described: the C-E technique, in which the thumb and index fingers of each hand form a C around the mask while the third, fourth, and fifth fingers pull the jaw towards the mask in an E shape, and the V-E technique, in which the thumbs and thenar eminence of each hand press against the sides of the mask in a V shape while the rest of the fingers perform the E jaw traction . Current evidence points to better performance of the V-E maneuver compared to the C-E maneuver. However, the performance of these maneuvers has not been uniformly evaluated with the use of adjuncts to face mask ventilation, such as the Guedel airway, or in patients under neuromuscular blockade. Given the lack of scientific evidence, the results of our research would not only impact the work of anesthesiologists but also extend to emergency services and prehospital settings. This would lead to improved patient outcomes by enhancing knowledge of two-hand mask ventilation and raising the quality of care provided to patients

Interventions

PROCEDUREV-E facial mask ventilation maneuver

The V-E maneuver is achieved by placing the thumbs and thenar eminence of each hand on the sides of the mask, creating a V shape, while the rest of the fingers perform a jaw thrust described as an E shape. This will be performed after anesthetic induction when the patient is unconscious and apneic. The C-E maneuver is achieved by placing the thumb and index finger of each hand on the mask in a C shape, while the third, fourth, and fifth fingers of both hands perform a jaw thrust towards the mask in an E shape. This will also be performed after anesthetic induction when the patient is unconscious and apneic.

PROCEDUREC-E facial mask ventilation maneuver

The C-E maneuver is achieved by placing the thumb and index finger of each hand on the mask in a C shape, while the third, fourth, and fifth fingers of both hands perform a jaw thrust towards the mask in an E shape. This will also be performed after anesthetic induction when the patient is unconscious and apneic.

Sponsors

Universidad de Antioquia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Generation of the Random Allocation Sequence The sequence will be generated using the latest version of R software with permuted blocks of 2, 4, and 6 participants with variable block sizes, and one stratification variable: use of an oropharyngeal cannula. Allocation Concealment Mechanism The allocation will be kept in an opaque envelope that does not allow the assigned group to be seen. Implementation The envelope will be opened only by one of the investigators after completing the inclusion criteria and signing the informed consent Blinding Patient: Will be blinded as they will be under general anesthesia Outcome Evaluator Will be blinded as their analysis will be conducted on videos recorded by the research team

Intervention model description

Controlled clinical trial with two parallel groups, randomized 1:1, superiority design, blinded to the patient and data analyst.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients over 18 years old * Scheduled for elective surgery * Require general anesthesia * Consent to participate in the study

Exclusion criteria

* Presence of predictors of difficult ventilation: presence of a beard, --obstructive sleep apnea/hypopnea syndrome * Anticipated difficult airway * Classified as ASA IV or higher * Oxygen saturation less than 92% upon admission * Requirement for supplemental oxygen

Design outcomes

Primary

MeasureTime frameDescription
Ventilation ml/kg10 minutes during procedureAverage ventilation in milliliters per kilogram of body weight for seven ventilations recorded on the anesthesia machine at the end of expiration.

Secondary

MeasureTime frameDescription
Average CO2 mmHg10 minutes during procedureAverage CO2 in mmHg for seven ventilations recorded on the anesthesia machine at the end of expiration.
Ineffective ventilation10 minutes during procedureProportion of ineffective ventilation, defined as ventilation less than 1.5 ml/kg.
Operator satisfaction.10 minutes during procedureOperator's perceived ease of use, on a Likert scale from 1 to 5, with 1 being very easy and 5 being very difficult.
Hypoxemia10 minutes during proceduredefined as SpO2 less than 92%

Other

MeasureTime frameDescription
Adverse events by group.Perioperative/PeriproceduralAdverse events by group.

Countries

Colombia

Contacts

Primary ContactMario Zamudio, Anesthesiologist
mario.zamudio@udea.edu.co+57 3003456596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026