N/A
Completed N=21
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
Noninvasive Ventilation
Source: ClinicalTrials.gov NCT03876873 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Maximal and Average Expiratory Tidal Volume During Mask Ventilation — 25; 26.52; 21.96; 23.33 Milliliter
Summary
Mask ventilation is fundamental to airway management at the start of surgical procedures requiring general anesthesia. For general anesthesia, medications are provided that affect the entire body and lead to a loss of consciousness. Medical professionals perform mask ventilation by placing a plastic mask over a subjects mouth and nose to provide enough oxygen for the placement of a breathing tube. In this study, we expect that a 45 degree rotation of the head will increase the efficiency of mask ventilation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal and Average Expiratory Tidal Volume During Mask Ventilation |
25; 26.52; 21.96; 23.33 | — |
| SECONDARY Maximal and Average Inspiratory Tidal Volume During Mask Ventilation |
415.48; 395.35; 339.86; 296.45 | — |
| SECONDARY Maximal and Average End-tidal CO2 (ETCO2) During Mask Ventilation |
23; 31.36; 18.59; 23.93 | — |
| SECONDARY Maximal and Average Airway Flow During Mask Ventilation |
97.69; 98.03; 97.95; 96.78 | — |
| SECONDARY Lowest and Delta O2 Saturation Drop on SpO2 During Mask Ventilation |
96.78; 95.73; 3.22; 4.18 | — |
| SECONDARY Lowest and Delta O2 Saturation Drop on SpO2 During Intubation |
2.28; 1.90; 3.22; 4.18 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- ASA Physical Status Classification I-III
- Body Mass Index (BMI) ≥ 35 kg/m^2
Exclusion Criteria
- Inability to obtain written informed consent
- Pregnant or breastfeeding
- Limited head rotation or neck extension
- Subjects with expected or history difficult intubation
- Large beard
- Orogastric (OG)/nasogastric (NG) tube
- Gastroesophageal Reflux Disease (GERD)
Data sourced from ClinicalTrials.gov (NCT03876873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.