NCT03606564

Brief Summary

This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

May 31, 2018

Last Update Submit

August 2, 2018

Conditions

Keywords

compliancefasting guidelines

Outcome Measures

Primary Outcomes (2)

  • Median duration of fasting

    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

    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 Outcomes (8)

  • Percentage of parents who attended Pre Anaesthesia Clinic

    1.5 years

  • Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic

    1.5 years

  • Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods

    1.5 years

  • Percentage of parents who could recall if fasting instructions were verbal or written orders

    1.5 years

  • Percentage of parents who received fasting instructions from anyone other than the anaesthetist

    1.5 years

  • +3 more secondary outcomes

Study Arms (1)

paediatric patients undergoing day care surgery

Other: study of fasting time among pediatric patients undergoing day care surgery

Interventions

parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and

paediatric patients undergoing day care surgery

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Consecutive children aged 1 to 12 years of ASA I and II category, scheduled to undergo elective day care surgery under general anaesthesia, were included in this prospective study

You may qualify if:

  • Children aged 1 to 12 years
  • ASA I and II category
  • Elective day care surgery
  • General anaesthesia planned

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research,

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

FastingPatient Compliance

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • indu bala, MD

    PGIMER, chandigarh, india

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2018

First Posted

July 31, 2018

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations