Effect of Paratracheal Pressure on Mask Ventilation

Sponsor

SMG-SNU Boramae Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05388266

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilation	Other: Mask ventilation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients

Anticipated Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Apr 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paratracheal pressure After the induction of anesthesia, paratracheal pressure is applied during mask ventilation.	Other: Mask ventilation Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.
Active Comparator: No pressure After the induction of anesthesia, no pressure is applied during mask ventilation.	Other: Mask ventilation Mask ventilation is performed under paratracheal pressure or no pressure in a randomized, crossover manner.

Arm

Intervention/Treatment

Experimental: Paratracheal pressure

After the induction of anesthesia, paratracheal pressure is applied during mask ventilation.

Other: Mask ventilation

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

Active Comparator: No pressure

After the induction of anesthesia, no pressure is applied during mask ventilation.

Other: Mask ventilation

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

Outcome Measures

Primary Outcome Measures

Expiratory tidal volume [For 2 min of mask ventilation after the induction of anesthesia]
Volume controlled mechanical ventilation is delivered during mask ventilation. Expiratory tidal volumes on the monitor screen are recorded during mask ventilation

Secondary Outcome Measures

Peak inspiratory pressure [For 2 min of mask ventilation after the induction of anesthesia]
Peak inspiratory pressure on the screen is recorded during mask ventilation.
Inadequate tidal volume [For 2 min of mask ventilation after the induction of anesthesia]
Incidence of tidal volume less than 150 mL is recorded.
Incidence of hypoxia [For 2 min of mask ventilation after the induction of anesthesia]
Occurrence of hypoxia (SpO2 <90%) is recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

SMG-SNU Boramae Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Young Hwang, Professor, SMG-SNU Boramae Medical Center

ClinicalTrials.gov Identifier:

NCT05388266

Other Study ID Numbers:

05112022

First Posted:

May 24, 2022

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 24, 2022