N/A N=21 Randomized Triple-blind Treatment

Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults

Noninvasive Ventilation

Bottom Line

View on ClinicalTrials.gov: NCT03876873 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Maximal and Average Expiratory Tidal Volume During Mask Ventilation — 25; 26.52; 21.96; 23.33 Milliliter

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Head Rotation During Face Mask Ventilation (Procedure); Medline Top Valve Anesthesia Mask (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Missouri-Columbia
Primary completion: Feb 2023

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.