- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406481
The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients
August 24, 2022 updated by: Marmara University
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Marmara University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pediatric patients undergoing surgery
Description
Inclusion Criteria: pediatric patients, aged between 5 to 12, undergoing surgery -
Exclusion Criteria: any comorbidity
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the relationship between fasting period duration and fluid responsiveness
Time Frame: March 2018
|
March 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
April 28, 2021
Study Completion (Actual)
April 28, 2021
Study Registration Dates
First Submitted
January 15, 2018
First Submitted That Met QC Criteria
January 15, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Actual)
August 25, 2022
Last Update Submitted That Met QC Criteria
August 24, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 09.2017.669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intravascular Volume
-
Tepecik Training and Research HospitalCompletedIntravascular VolumeTurkey
-
Johannes Gutenberg University MainzCompletedIntravascular Volume | Respiratory ChangesGermany
-
Beni-Suef UniversityUnknownIntravascular VolumeEgypt
-
Trabzon Kanuni Education and Research HospitalRecruitingHemodynamic Changes | Lumbar Spine Surgery | Intravascular Volume StatusTurkey (Türkiye)
-
Ain Shams UniversityActive, not recruitingComparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal SurgeriesEgypt
-
Tanta UniversityCompletedIntravascular Volume | Spinal Induced Hypotension | Geriatric PopulationEgypt
-
Charles University, Czech RepublicUnknownSeptic Shock | Vein Collapsibility | Intravascular Doppler | Volume Responsiveness in Septic ShockCzechia
-
University of MiamiCompletedCoagulation; IntravascularUnited States
-
Hospital Central de la Defensa Gómez UllaUnknownIntravascular Catheter ColonizationSpain
-
Keimyung University Dongsan Medical CenterCompletedIntravascular InjectionKorea, Republic of