- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606564
Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients
Parent's Perception and Compliance With Pre-operative Fasting Instructions in Paediatric Patients Undergoing Day Care Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are instructed to adhere to these guidelines. Parents might not be compliant with these instructions. They may fast their children less than or more than the recommended time.
Main aim of this study is to find out the incidence of non compliance with the fasting instructions and try to find the reasons for such non compliance.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Chandigarh, India, 160012
- Post Graduate Institute of Medical Education and Research,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 1 to 12 years
- ASA I and II category
- Elective day care surgery
- General anaesthesia planned
Exclusion Criteria
- Parent's refusal to participate.
- Children with complex nutritional requirements eg. feeding via gastrostomy tube
- Parents who cannot read or understand English, Hindi or Punjabi
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
paediatric patients undergoing day care surgery
|
parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median duration of fasting
Time Frame: 1.5 years
|
Median time of pre operative fasting as advised by anaesthesiologist/surgeon/nurse in the Pre Anaesthesia Clinic was compared with the Median duration of fasting of the patient just before surgery.
|
1.5 years
|
Percentage of parents who followed the preoperative fasting instructions
Time Frame: 1.5 years
|
Percentage of parents who adhered to advised fasting time was compared with percentage of parents who fasted their children more than or less than what was advised.
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of parents who attended Pre Anaesthesia Clinic
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who could recall if fasting instructions were verbal or written orders
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who received fasting instructions from anyone other than the anaesthetist
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who understood the actual reason to fast before surgery
Time Frame: 1.5 years
|
1.5 years
|
Percentage of patients who were not adequately fasted.
Time Frame: 1.5 years
|
1.5 years
|
Percentage of parents who complained about fasting time being too long for their children
Time Frame: 1.5 years
|
1.5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: indu bala, MD, PGIMER, Chandigarh, India
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 9605/PG-2Trg/2013/13402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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