Two-hand face-mask hold (C-E vs V-E) during general anesthesia
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
NA · Universidad de Antioquia · NCT07179432
This will test whether the two-hand C-E or V-E face-mask hold helps adults under general anesthesia breathe more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Antioquia (other) |
| Locations | 2 sites (Medellín, Antioquia and 1 other locations) |
| Trial ID | NCT07179432 on ClinicalTrials.gov |
What this trial studies
On the day of elective surgery, after the patient is asleep under general anesthesia, the clinician will use one of two two-hand mask-holding techniques (C-E or V-E) for a short period. Investigators will record how well the patient is ventilated, measure end-tidal carbon dioxide, and collect the clinician's rating of ease and comfort using each technique. No other aspects of the planned surgery or recovery will be changed by participation. The trial is being conducted at Universidad de Antioquia–affiliated clinical sites in Medellín, Colombia.
Who should consider this trial
Good fit: Adults over 18 scheduled for elective surgery under general anesthesia who consent and do not have predictors of difficult mask ventilation or need supplemental oxygen are appropriate candidates.
Not a fit: People with predicted difficult airways, obstructive sleep apnea, a beard, ASA class IV or higher, oxygen saturation below 92% on admission, or anyone requiring supplemental oxygen are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If one technique works better, it could make mask ventilation safer and easier during anesthesia and emergency airway care, potentially reducing airway-related problems.
How similar studies have performed: Previous comparisons of mask-holding techniques have been performed but show mixed results, so direct head-to-head trials like this are still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Medellín, Antioquia and 1 other locations
- Hospital alma Mater de Antioquia — Medellín, Antioquia, Colombia (RECRUITING)
- Antioquia´s University — Medellín, Colombia (RECRUITING)
Study contacts
- Principal investigator: Mario Zamudio, Anesthesiologist — Universidad de Antioquia
- Study coordinator: Mario Zamudio, Anesthesiologist
- Email: mario.zamudio@udea.edu.co
- Phone: +57 3003456596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: General Anesthetics, ventilation, mask ventilation