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
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Other: Carbohydrate beverage||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159636
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