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出境医 / 临床实验 / Effect of Semi-sitting Position on Mask Ventilation

Effect of Semi-sitting Position on Mask Ventilation

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 Not Applicable

Study Design
Layout table for study information
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
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.
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE March 9, 2020
Actual Primary Completion Date June 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2020) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Expiratory tidal volume [ Time Frame: 1 min after the induction of anesthesia ]
    Expiratory tidal volume is assessed during mask ventilation in the supine and semi-sitting positions.
  • Grading scale for mask ventilation [ Time Frame: during mask ventilation ]
    The grading scale for mask ventilation is graded in both supine and semi-sitting positions as follows: one, ventilated by a mask; two, ventilated by a mask with an oral airway/adjuvant; three, difficult mask ventilation (inadequate, unstable, or requiring two provider) ; four, unable to ventilate by a mask.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2020)
  • 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
  • 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.
  • Peak inspiratory pressure [ Time Frame: during mask ventilation ]
    Peak inspiratory pressure is recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Minute ventilation during mask ventilation in the supine and semi-sitting positions [ Time Frame: 1 min after anesthesia induction ]
    Minute ventilation is assessed during
  • 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.
  • The incidence of hypoxia [ Time Frame: during mask ventilation ]
    The incidence of desaturation (SpO2<90%) is recorded.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Semi-sitting Position on Mask Ventilation
Official Title  ICMJE Effect of Semi-sitting Position on Mask Ventilation in Anesthetized and Paralyzed Patients
Brief Summary We compare the effect on semi-sitting position on mask ventilation in anesthetized and paralyzed obese patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Ventilation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Supine position
    After the induction of anesthesia, mask ventilation is performed in the supine position.
    Intervention: Other: patient position
  • Experimental: Semi-sitting position
    After the induction of anesthesia, mask ventilation is performed in the semi-sitting position.
    Intervention: Other: patient position
Publications * Chang JE, Seol T, Hwang JY. Body position and the effectiveness of mask ventilation in anaesthetised paralysed obese patients: A randomised cross-over study. Eur J Anaesthesiol. 2021 Feb 9. doi: 10.1097/EJA.0000000000001473. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2020) 		38
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		70
Actual Study Completion Date  ICMJE June 8, 2020
Actual Primary Completion Date June 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03996161
Other Study ID Numbers  ICMJE 2019-1231
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin-Young Hwang, SMG-SNU Boramae Medical Center
Study Sponsor  ICMJE SMG-SNU Boramae Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SMG-SNU Boramae Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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