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NCT05388266 Clinical Trial

Effect of Paratracheal Pressure on Mask Ventilation

Ventilation Clinical Trial

Official title:
Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05388266
Other study ID # 05112022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 4, 2022
Est. completion date October 20, 2022

Study information
Verified date October 2022
Source SMG-SNU Boramae Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 20, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expiratory tidal volume Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation For 2 min of mask ventilation after the induction of anesthesia
Secondary Peak inspiratory pressure Peak inspiratory pressure on the screen is recorded during mask ventilation. For 2 min of mask ventilation after the induction of anesthesia
Secondary Inadequate tidal volume Incidence of tidal volume less than 150 mL is recorded. For 2 min of mask ventilation after the induction of anesthesia
Secondary Incidence of hypoxia Occurrence of hypoxia (SpO2 <90%) is recorded. For 2 min of mask ventilation after the induction of anesthesia
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