Fasting PeriodNCT03406481
The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
An observational study of Fasting Period and Intravascular Volume, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Fasting Period, Intravascular Volume
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 28 Apr 2021
- Phase
- Observational
- 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 5 to 12 years
- All sexes
- Child
Study population: pediatric patients undergoing surgery
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered intraoperatively. Cardiac preload static indicators are often insufficient to predict the need for fluid and are often measured by invasive methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the investigators aimed to determine the effect of preoperative fasting period on cardiac index change after anesthesia induction in pediatric patients aged 5-12 years. The primary implication of this study is to determine the fasting period of fluid evacuation by assessing patients' intravascular volume status.
- Conditions
- Fasting Period, Intravascular Volume
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between fasting period duration and fluid responsiveness
Measured: March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting PeriodStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406481
- Sponsor's protocol ID
- 09.2017.669
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2018
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03406481
- Acronym / sponsor ID
- 09.2017.669
- Conditions
- Fasting Period, Intravascular Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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 minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered intraoperatively. Cardiac preload static indicators are often insufficient to predict the need for fluid and are often measured by invasive methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the investigators aimed to determine the effect of preoperative fasting period on cardiac index change after anesthesia induction in pediatric patients aged 5-12 years. The primary implication of this study is to determine the fasting period of fluid evacuation by assessing patients' intravascular volume status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- pediatric patients undergoing surgery
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the relationship between fasting period duration and fluid responsiveness
Time frame: March 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting Period and Intravascular Volume, run by Marmara University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 25 Aug 2022. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the relationship between fasting period duration and fluid responsiveness (time frame: March 2018). 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 25 Aug 2022.