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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Antioquia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients over 18 years old

Scheduled for elective surgery

Require general anesthesia

Consent to participate in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • V-E facial mask ventilation maneuver

    Procedure/Surgery

    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.

  • C-E facial mask ventilation maneuver

    Procedure/Surgery

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: Two-Hand V-E Maneuver Facial Mask Ventilation.Experimental treatment 1 intervention
Group B: C-E facial mask ventilation maneuverActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilation ml/kg

Average ventilation in milliliters per kilogram of body weight for seven ventilations recorded on the anesthesia machine at the end of expiration.

Time frame
10 minutes during procedure

Secondary outcomes

1

Average CO2 mmHg

Average CO2 in mmHg for seven ventilations recorded on the anesthesia machine at the end of expiration.

Time frame
10 minutes during procedure
2

Ineffective ventilation

Proportion of ineffective ventilation, defined as ventilation less than 1.5 ml/kg.

Time frame
10 minutes during procedure
3

Operator satisfaction.

Operator's perceived ease of use, on a Likert scale from 1 to 5, with 1 being very easy and 5 being very difficult.

Time frame
10 minutes during procedure
4

Hypoxemia

defined as SpO2 less than 92%

Time frame
10 minutes during procedure

Other outcomes

1

Adverse events by group.

Adverse events by group.

Time frame
Perioperative/Periprocedural

Sponsors and contacts

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