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Comparison of the effectiveness of two-handed mask ventilation techniques (VE and "aa" technique) by anesthesiologists with small hand size: a double-blind randomized crossover trial.

Comparison of the effectiveness of two-handed mask ventilation techniques (VE and "aa" technique) by anesthesiologists with small hand size: a double-blind randomized crossover trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1010250039
Enrollment
56
Registered
2025-10-03
Start date
2025-10-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Non-cardiac surgery performed under general anesthesia

Interventions

Randomly assign two-handed mask ventilation technique (1) and (2) for induction of anesthesia, and perform one of them first, followed by the other technique. (1) VE technique (2) "aa" technique

Sponsors

Suda Yasuhiro
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing general anesthesia for non-cardiac surgery 2. Patients who are 18 years of age or older and under 90 years of age at the time of obtaining consent 3. Patients who provided written consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patients for whom aspiration or difficult airway management are anticipated, requiring sequenc rapid or awake intubation 2. Patients with chronic or acute respiratory diseases including asthma and chronic obstructive pulmonary disease 3. Patients with cervical spine disorders, including rheumatoid arthritis or cervical spondylosis, that require restriction of neck movement 4. Patients undergoing emergency surgery 5. Pregnant women or those undergoing cesarean section 6. Patients with ASA physical status of 4 or higher 7. Patients with allergies to protocol medications (remifentanil, propofol, rocuronium) 8. Others deemed unsuitable as subjects by the attending physician

Design outcomes

Primary

MeasureTime frame
The primary outcome is the tidal volume after loss of consciousness, divided by the predicted body weight. The difference between the two-handed mask ventilation will be compared. Mask ventilation is performed five times. The first two times are excluded from measurement to allow fresh gas to fill the anesthesia circuit and reach equilibrium. The tidal volumes of the subsequent three breaths will be measured, and their average will be calculated. A paired t-test is performed to determine whether there is a significant difference between the two groups and to calculate the 95% confidence interval.

Secondary

MeasureTime frame
The secondary outcomes are tidal volume, tidal volume divided by actual body weight, and the frequency of ventilatory failure (tidal volume is less than or equal to anatomical dead space). After administration of muscle relaxants and confirmation of sufficient muscle relaxation (disappearance of T1 on TOF monitoring), tidal volume divided by predicted body weight, tidal volume, and tidal volume divided by actual body weight are also measured in the same manner. Statistical tests are performed between the two groups to determine whether there is a significant difference. Paired t-test or Wilcoxon signed rank test are performed, and 95 % confidence intervals are calculated. Before induction of anesthesia, confirm the fit of the mask using both techniques and investigate the relationship between the posterior margin of the mandibular ramus and the position of the anesthesiologist's fingers. The McNemar test is used to determine whether there is a significant difference between the two methods. If necessary, the relationship between tidal volume and other factors is also examined. The frequency of leaks is also tested using the McNemar test to determine if there is a significant difference between the two methods.

Contacts

Public ContactYasuhiro Suda

Asahikawa Medical University

suda0223@asahikawa-med.ac.jp+81-8060652302

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026