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Effect of Semi-sitting Position on Mask Ventilation

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ClinicalTrials.gov Identifier: NCT03996161
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 9, 2020
Actual Primary Completion Date : June 8, 2020
Actual Study Completion Date : June 8, 2020

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.




Primary Outcome Measures :
  1. Expiratory tidal volume [ Time Frame: 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 :
  1. Minute ventilation during mask ventilation in the supine and semi-sitting positions [ Time Frame: 1 minute after anesthesia induction ]
    Minute ventilation is assessed during mask ventilation

  2. The incidence of inadequate mask ventilation or dead space ventilation. [ Time Frame: during mask ventilation ]
    The incidence of inadequate mask ventilation or dead space ventilation is recorded.

  3. Peak inspiratory pressure [ Time Frame: during mask ventilation ]
    Peak inspiratory pressure is recorded.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996161


Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
SMG-SNU Boramae Medical Center
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Responsible Party: Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT03996161    
Other Study ID Numbers: 2019-1231
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No