Duration of Preoperative FastingNCT00545636
The Influence of Education of Medical Team on Duration of Fasting Before Elective Medical Interventions Performed Under General Anesthesia in Children
A study testing education in people with Duration of Preoperative Fasting, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to examine if an education program of the medical teams can help implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory medical interventions under anesthesia and decrease unnecessary long fasting. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Duration of Preoperative Fasting
- What is being tested?
- education
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children who are about to undergo anesthesia for elective medical interventions,
- Age 0-18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to examine if an education program of the medical teams can help implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and regular eating and drinking habits. Thereafter, all medical teams involved with the administration of NPO orders will receive an educational program to explain and implement the NPO orders as are recommended by the American Society of Anesthesiologists. We will examine if the educational program was successful in reducing unnecessary long period of fasting, and if such a program is not associated with increased rate of delay of cases.
- Conditions
- Duration of Preoperative Fasting
- Being tested
- education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
The intervention is an education of the medical teams that instruct children to fast before the administration of general anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Education of the medical teams as to preoperative fasting time will aid in shortening of an unnecessary prolonged fasting
Measured: Immediate pre-anesthesia period (to assess lenth ofpreoperative fasting time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startMar 2008
- Primary completionMar 2009 (estimated)
Why it stopped: unfortunately lacked manpower to carry out the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of Preoperative FastingStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ze'ev Shenkman, MD, Principal investigator, Sheba Medical Center, Department of Anesthsia C and Department of AnesthesiaHaim Berkenstadt, MD, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545636
- Sponsor's protocol ID
- SHEBA-07-4879-ZS-CTIL
- Status last verified
- Jun 2012
- First submitted
- 16 Oct 2007
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Education of Medical Team on Duration of Fasting Before Elective Medical Interventions Performed Under General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT00545636
- Acronym / sponsor ID
- SHEBA-07-4879-ZS-CTIL
- Conditions
- Duration of Preoperative Fasting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unfortunately lacked manpower to carry out the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (estimated)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine if an education program of the medical teams can help implementation of of NPO (nothing-per-os)orders in children before anesthesia for ambulatory medical interventions under anesthesia and decrease unnecessary long fasting. We shall ask parents of such children to fill in a questionnaire regarding pre-anesthesia fasting and regular eating and drinking habits. Thereafter, all medical teams involved with the administration of NPO orders will receive an educational program to explain and implement the NPO orders as are recommended by the American Society of Anesthesiologists. We will examine if the educational program was successful in reducing unnecessary long period of fasting, and if such a program is not associated with increased rate of delay of cases.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children who are about to undergo anesthesia for elective medical interventions,
- Age 0-18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationThe intervention is an education of the medical teams that instruct children to fast before the administration of general anesthesia | Other | – |
Primary outcome
Education of the medical teams as to preoperative fasting time will aid in shortening of an unnecessary prolonged fasting
Time frame: Immediate pre-anesthesia period (to assess lenth ofpreoperative fasting time)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2012.
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Effect of Preoperative Fasting Duration on Postoperative Pain and Emergence Agitation in Pediatric Patients Undergoing Urogenital Surgery
Postoperative Pain, Emergence Delirium
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A Comparative Study of Preoperative Carbohydrate Loading Dose and Fasting on Postoperative Recovery Time in Elective Abdominal Surgery Patients
This Study Mainly Focus on the Eras Protocol Decreasing Time of Npo and Early Discharge From Hospital to Avoid Hospital Acquired Infections
RecruitingObservational study
"Duration of Preoperative Clear Fluids Fasting in Patients Undergoing Liver Transplant"
Preoperative Clear Fluid Fasting, Liver Transplant Recipient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ze'ev Shenkman, MD principal investigator
Sheba Medical Center, Department of Anesthsia C and Department of Anesthesia
Haim Berkenstadt, MD study director
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Duration of Preoperative Fasting, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Education of the medical teams as to preoperative fasting time will aid in shortening of an unnecessary prolonged fasting (time frame: Immediate pre-anesthesia period (to assess lenth ofpreoperative fasting time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2012.