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Effect of Paratracheal Pressure on Mask Ventilation

Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05388266
Enrollment
50
Registered
2022-05-24
Start date
2022-07-04
Completion date
2022-10-20
Last updated
2022-11-01

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

Conditions

Ventilation

Brief summary

This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.

Interventions

Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.

Sponsors

SMG-SNU Boramae Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery

Exclusion criteria

* Structural abnormalities or diseases in the face, neck, upper airway, or esophagus * Increased risk of aspiration (pregnancy) * Carotid artery stenosis, cerebrovascular disease

Design outcomes

Primary

MeasureTime frameDescription
Expiratory tidal volumeFor 2 min of mask ventilation after the induction of anesthesiaVolume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation

Secondary

MeasureTime frameDescription
Peak inspiratory pressureFor 2 min of mask ventilation after the induction of anesthesiaPeak inspiratory pressure on the screen is recorded during mask ventilation.
Inadequate tidal volumeFor 2 min of mask ventilation after the induction of anesthesiaIncidence of tidal volume less than 150 mL is recorded.
Incidence of hypoxiaFor 2 min of mask ventilation after the induction of anesthesiaOccurrence of hypoxia (SpO2 \<90%) is recorded.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026