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Pulmonary Aspiration in Elderly Patients

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ClinicalTrials.gov Identifier: NCT04159636
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Eunah Cho, MD, Kangbuk Samsung Hospital

Brief Summary:
The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.

Condition or disease Intervention/treatment Phase
Anesthesia Other: Carbohydrate beverage Not Applicable

Detailed Description:

Recently, carbohydrate loading is suggested for enhanced recovery after surgery.

Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients.

This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group
Estimated Study Start Date : February 25, 2020
Estimated Primary Completion Date : February 26, 2020
Estimated Study Completion Date : February 27, 2020

Arm Intervention/treatment
No Intervention: Fasting group
Participants will be remained fasted until surgery
Experimental: Carbohydrate group
Participants will be allowed to drink carbohydrate beverage before 2 hours of surgery
Other: Carbohydrate beverage
The participants in this group are allowed to drink carbohydrate until 2 hours before surgery




Primary Outcome Measures :
  1. Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2 [ Time Frame: 2 hours after intake of last allowable carbohydrate drink time ]

    Incidence of Perlas grade 2. Clear fluid is detected in gastric antrum by gastric antral ultrasound on both supine and right lateral decubitus position.

    Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions.



Secondary Outcome Measures :
  1. cross-sectional area of gastric antrum in supine position [ Time Frame: 2 hours after intake of last allowable carbohydrate drink time ]
    cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4

  2. cross-sectional area of gastric antrum in right decubitus position [ Time Frame: 2 hours after intake of last allowable carbohydrate drink time ]
    cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged from 65
  • scheduled for elective surgery
  • American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

  • Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus)
  • psychiatric or mental disorders
  • delirium
  • dementia
  • parkinsonism
  • alcoholism
  • drug abuse

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): NCT04159636


Contacts
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Contact: Eunah Cho 82-2-2001-2314 mintflavored@naver.com

Sponsors and Collaborators
Kangbuk Samsung Hospital
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Responsible Party: Eunah Cho, MD, Clinical Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT04159636    
Other Study ID Numbers: KBSMC 2019-10-013
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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