Effect of Semi-sitting Position on Mask Ventilation

Sponsor

SMG-SNU Boramae Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03996161

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients

Condition or Disease	Intervention/Treatment	Phase
Ventilation	Other: patient position	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients

Actual Study Start Date :

Mar 9, 2020

Actual Primary Completion Date :

Jun 8, 2020

Actual Study Completion Date :

Jun 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Supine position After the induction of anesthesia, mask ventilation is performed in the supine position.	Other: patient position After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.
Experimental: Semi-sitting position After the induction of anesthesia, mask ventilation is performed in the semi-sitting position.	Other: patient position After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.

Arm

Intervention/Treatment

Active Comparator: Supine position

After the induction of anesthesia, mask ventilation is performed in the supine position.

Other: patient position

After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.

Experimental: Semi-sitting position

After the induction of anesthesia, mask ventilation is performed in the semi-sitting position.

Other: patient position

After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.

Outcome Measures

Primary Outcome Measures

Expiratory tidal volume [1 minute after the induction of anesthesia]
Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.

Secondary Outcome Measures

Minute ventilation during mask ventilation in the supine and semi-sitting positions [1 minute after anesthesia induction]
Minute ventilation is assessed during mask ventilation
The incidence of inadequate mask ventilation or dead space ventilation. [during mask ventilation]
The incidence of inadequate mask ventilation or dead space ventilation is recorded.
Peak inspiratory pressure [during mask ventilation]
Peak inspiratory pressure is recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Obese patients undergoing general anesthesia

Exclusion Criteria:

diseases or structural abnormalities in the upper airway
those who were at risk of aspiration
cardiovascular or respiratory diseases
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of

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, Associate professor, SMG-SNU Boramae Medical Center

ClinicalTrials.gov Identifier:

NCT03996161

Other Study ID Numbers:

2019-1231

First Posted:

Jun 24, 2019

Last Update Posted:

Jun 11, 2020

Last Verified:

Jun 1, 2020

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

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

Study Results

No Results Posted as of Jun 11, 2020