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NPO Before Sedation

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05810532
Collaborator
(none)
68
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.

Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).

Condition or Disease Intervention/Treatment Phase
  • Other: 4 hours of fasting time
  • Other: 1 hour of fasting time
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 4H group

fasting more than 4 hours before sedation

Other: 4 hours of fasting time
Oral intake is not allowed for 4 hours before sedation including water
Experimental: 1H group

oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation

Other: 1 hour of fasting time
Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation

Outcome Measures

Primary Outcome Measures

  1. Gastric astral cross-sectional area [10 minutes before sedation]

    Gastric astral cross-sectional area measured with gastric ultrasound

Secondary Outcome Measures

  1. Estimated gastric volume [10 minutes before sedation]

    Calculated gastric volume using the formula

  2. Perlas grade [10 minutes before sedation]

    Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration

  3. Quality of sdeation [10 minutes after sedation]

    0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Children scheduled for elective echocardiography

  • Aged under 3 years old

Exclusion Criteria:

  • Comorbidity other than hear disease or chromosomal disease

  • Patients with delayed gastric emptying

  • Patients with structural abnormalities of the stomach or esophagus

  • Difficult airway management

  • Parents refuse to participate in the study

  • Unable to achieve sedation

  • Neonatal

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kangbuk Samsung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eunah Cho, MD, Assistant Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT05810532
Other Study ID Numbers:
  • NPO1
First Posted:
Apr 12, 2023
Last Update Posted:
Apr 12, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 12, 2023