TAPSEFASTİNGTAPSENCT05703321
The Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Movement in Female Patients
An observational study of TAPSE, run by Aydin Maternity and Child Health Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia. It is already known that this fasting period affects volume. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- TAPSE
- What is being tested?
- preoperative fasting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2022to 21 May 2023
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: who will undergo elective procedures under anesthesia
Who may be able to join
- ASA 1-2
- Being between the ages of 18-65
- Having no peroperative hydration
- Preoperative sedative not given
- No known heart disease
Who cannot join
- Being pregnant
- Post cardiac surgery
- Severe pulmonary hypertension
- Severe valve disease
- Hypertrophic or dilated cardiomyopathy
- Presence of acute myocardial infarction
- Non-sinus rhythm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aydin Maternity and Child Health Hospital
Aydin
Ferdi Gülaştı, +905054929650, ferdigulasti@icloud.com
Ferdi Gülaştı, ferdigulasti@icloud.com
About this study
Background Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia. It is already known that this fasting period affects volume. Although Tricuspid Annular Plane Systolic Movement (TAPSE) is an echocardiographic parameter showing Right Ventricular (RV) systolic function, its relationship with volume is discussed in recent years. In the present study, the relationship between TAPSE and volume, and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.
Methods The study was started between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital after approval was received from the Non-Invasive Clinical Research Ethics Committee. A total of 21 patients were planned to be included in this prospective observational study. Transthoracic echocardiography will be performed in patients aged 18-65 years who will undergo elective procedures under anesthesia, and in full patients the day before surgery. Those who are pregnant, patients with known or prospective severe valvular disease, severe pulmonary hypertension, acute myocardial infarction, dilated and hypertrophic cardiomyopathy, and non-sinus rhythm will be excluded from the study. Transthoracic echocardiography will be performed on the patients, and the relationship between TAPSE and volume and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.
Read the detailed description
It is already known that right ventricular systolic dysfunction has prognostic value in various pathological conditions. Evaluating RV function with echocardiography is difficult because of the complex geometry of the RV. Although RV function was evaluated only visually for many years, guidelines have been published by the American Society of Echocardiography as a result of studies conducted in recent years. In this respect, abnormal RV function must be suspected in case of one of the following criteria S'<10 cm/s, TAPSE <16 mm, RVFAC <35%, or R-MPI (tissue Doppler) > 0.55. Combining multiple measures of RV function can more reliably distinguish normal from abnormal function. TAPSE is a parameter that can be easily measured for apex-basal shortening and gives specific information about the global RV function. When compared to other measures of RV function, it is less dependent on optimal image quality and easier to measure. Low TAPSE is not very common but has been measured in some individuals without heart disease because of measurement errors, diagnostic misclassification, and extremes of the normal spectrum. It was shown in the study conducted by Gullupınar et al. that TAPSE decreased significantly after blood donation in people who had donated blood. Also, studies are trying to determine a relationship between central venous pressure, which is a volume indicator, and TAPSE. There is also a study that reported a relationship between cardiac MRI and CT and the right ventricle.
The purpose of the present study is to try to correlate the volume change of TAPSE because of preoperative hunger and to determine whether there is a change in preoperative fasting and right ventricular functions.
Purpose: To show whether there is a relationship between volume and TAPSE. To determine the relationship of TAPSE with preload and its usability for this purpose, and whether there is a change in preoperative fasting and right ventricular functions.
Hypothesis: TAPSE value is related to volume.
Material Method The study will start between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital, after the approval of the Non-Invasive Clinical Research Ethics Committee. Measurements will be made and recorded with Transthoracic Echocardiography (TTE) one day before the surgery, and TTE again if the preoperative fasting times on the day of the operation are appropriate in patients aged between 18-65 years who will undergo elective procedures under anesthesia. TTE will be made by the principal investigator Ferdi GULASTI. The demographic characteristics of the patients, preoperative blood values, heart rate during TTE, oxygen saturation (SaO2), Systolic Arterial Pressure (SAP), Diastolic Arterial Pressure (DAP), and Mean Arterial Pressure (MAP) will be recorded. The data will be compared statistically after the data collection process for the study is completed.
Echocardiography TTE will be performed on all patients in the left lateral decubitus position with the Echocardiography Device by the same observer. The values of all parameters will be recorded by taking the mean values of three cardiac cycle measurements. The measurement methods will be performed in line with the Guidelines of the American Society of Echocardiography. M-Mode, 2D (2D) images, color, pulse, and Continuous Wave Doppler and Tissue Doppler measurements will be taken from all participants in line with standard echocardiographic application methods. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long-axis view.
FACs, S' rates, TAPSE scores, and TDI-derived Myocardial Performance Indices (MPI) will be measured to assess Right Ventricular (RV) systolic functions. Tricuspid E and A wave velocity, E/A ratio, and E' velocity will be measured to assess the diastolic function of the RV. TAPSE will be calculated by placing an M-mode cursor across the Tricuspid Ring and measuring the amount of longitudinal movement in peak systole. Annular peak systolic velocity (S), early (E'), and late (A') peak annular diastolic velocities, Ejection Time (ET), IVRT, and Isovolumetric Contraction Time (IVCT) will be measured from the TDI images. TDI-induced MPI will be calculated as the sum of IVCT and IVRT divided by ET (MPI = (IVRT + IVCT) / ET) as a global estimate of both the systolic and diastolic functions of the RV.
The patients will be visualized in the supine position and through the subxiphoid window of the Inferior Vena Cava (IVC). The cursor will be placed 1 cm distal to the hepatic vein IVC entry point and the IVC diameter will be monitored for 30 seconds in M-Mode. The measurement will be made from the region where the diameter of the inferior vena cava is in inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. The Inferior Vena Cava Depression Rate (IVC-CI) will be calculated by using the formula IVC-CI = (IVCexp - IVCins)/IVCexp.
- Conditions
- TAPSE
- Being tested
- preoperative fasting
- Keywords
- Preoperative Fasting, volume, Tricuspid Annular Plane Systolic Movement, right ventricle function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative fastingBehavioural
Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
TAPSE volume
TAPSE, which is the right ventricular systolic function value, decreases after fasting, which is desired before the surgery
Measured: 6 month
Secondary outcomes (1)
fasting RV function
fasting is related to RV function
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start21 Nov 2022
- Primary completion21 May 2023 (estimated)
- Study completion21 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAPSEStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703321
- Sponsor's protocol ID
- 2022/185
- Acronym
- FASTİNGTAPSE
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: study protocol and statistical analysis available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Movement in Female Patients
- ClinicalTrials.gov ID
- NCT05703321
- Acronym / sponsor ID
- FASTİNGTAPSE / 2022/185
- Conditions
- TAPSE
- Keywords
- Preoperative Fasting, volume, Tricuspid Annular Plane Systolic Movement, right ventricle function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Aydin Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 21 May 2023 (estimated)
- Study completion
- 21 May 2023 (estimated)
- First posted
- 30 Jan 2023 (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.
Background Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia. It is already known that this fasting period affects volume. Although Tricuspid Annular Plane Systolic Movement (TAPSE) is an echocardiographic parameter showing Right Ventricular (RV) systolic function, its relationship with volume is discussed in recent years. In the present study, the relationship between TAPSE and volume, and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.
Methods The study was started between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital after approval was received from the Non-Invasive Clinical Research Ethics Committee. A total of 21 patients were planned to be included in this prospective observational study. Transthoracic echocardiography will be performed in patients aged 18-65 years who will undergo elective procedures under anesthesia, and in full patients the day before surgery. Those who are pregnant, patients with known or prospective severe valvular disease, severe pulmonary hypertension, acute myocardial infarction, dilated and hypertrophic cardiomyopathy, and non-sinus rhythm will be excluded from the study. Transthoracic echocardiography will be performed on the patients, and the relationship between TAPSE and volume and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.
Detailed description
It is already known that right ventricular systolic dysfunction has prognostic value in various pathological conditions. Evaluating RV function with echocardiography is difficult because of the complex geometry of the RV. Although RV function was evaluated only visually for many years, guidelines have been published by the American Society of Echocardiography as a result of studies conducted in recent years. In this respect, abnormal RV function must be suspected in case of one of the following criteria S'<10 cm/s, TAPSE <16 mm, RVFAC <35%, or R-MPI (tissue Doppler) > 0.55. Combining multiple measures of RV function can more reliably distinguish normal from abnormal function. TAPSE is a parameter that can be easily measured for apex-basal shortening and gives specific information about the global RV function. When compared to other measures of RV function, it is less dependent on optimal image quality and easier to measure. Low TAPSE is not very common but has been measured in some individuals without heart disease because of measurement errors, diagnostic misclassification, and extremes of the normal spectrum. It was shown in the study conducted by Gullupınar et al. that TAPSE decreased significantly after blood donation in people who had donated blood. Also, studies are trying to determine a relationship between central venous pressure, which is a volume indicator, and TAPSE. There is also a study that reported a relationship between cardiac MRI and CT and the right ventricle.
The purpose of the present study is to try to correlate the volume change of TAPSE because of preoperative hunger and to determine whether there is a change in preoperative fasting and right ventricular functions.
Purpose: To show whether there is a relationship between volume and TAPSE. To determine the relationship of TAPSE with preload and its usability for this purpose, and whether there is a change in preoperative fasting and right ventricular functions.
Hypothesis: TAPSE value is related to volume.
Material Method The study will start between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital, after the approval of the Non-Invasive Clinical Research Ethics Committee. Measurements will be made and recorded with Transthoracic Echocardiography (TTE) one day before the surgery, and TTE again if the preoperative fasting times on the day of the operation are appropriate in patients aged between 18-65 years who will undergo elective procedures under anesthesia. TTE will be made by the principal investigator Ferdi GULASTI. The demographic characteristics of the patients, preoperative blood values, heart rate during TTE, oxygen saturation (SaO2), Systolic Arterial Pressure (SAP), Diastolic Arterial Pressure (DAP), and Mean Arterial Pressure (MAP) will be recorded. The data will be compared statistically after the data collection process for the study is completed.
Echocardiography TTE will be performed on all patients in the left lateral decubitus position with the Echocardiography Device by the same observer. The values of all parameters will be recorded by taking the mean values of three cardiac cycle measurements. The measurement methods will be performed in line with the Guidelines of the American Society of Echocardiography. M-Mode, 2D (2D) images, color, pulse, and Continuous Wave Doppler and Tissue Doppler measurements will be taken from all participants in line with standard echocardiographic application methods. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long-axis view.
FACs, S' rates, TAPSE scores, and TDI-derived Myocardial Performance Indices (MPI) will be measured to assess Right Ventricular (RV) systolic functions. Tricuspid E and A wave velocity, E/A ratio, and E' velocity will be measured to assess the diastolic function of the RV. TAPSE will be calculated by placing an M-mode cursor across the Tricuspid Ring and measuring the amount of longitudinal movement in peak systole. Annular peak systolic velocity (S), early (E'), and late (A') peak annular diastolic velocities, Ejection Time (ET), IVRT, and Isovolumetric Contraction Time (IVCT) will be measured from the TDI images. TDI-induced MPI will be calculated as the sum of IVCT and IVRT divided by ET (MPI = (IVRT + IVCT) / ET) as a global estimate of both the systolic and diastolic functions of the RV.
The patients will be visualized in the supine position and through the subxiphoid window of the Inferior Vena Cava (IVC). The cursor will be placed 1 cm distal to the hepatic vein IVC entry point and the IVC diameter will be monitored for 30 seconds in M-Mode. The measurement will be made from the region where the diameter of the inferior vena cava is in inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. The Inferior Vena Cava Depression Rate (IVC-CI) will be calculated by using the formula IVC-CI = (IVCexp - IVCins)/IVCexp.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- who will undergo elective procedures under anesthesia
Key inclusion criteria (5 listed)
- ASA 1-2
- Being between the ages of 18-65
- Having no peroperative hydration
- Preoperative sedative not given
- No known heart disease
Key exclusion criteria (7 listed)
- Being pregnant
- Post cardiac surgery
- Severe pulmonary hypertension
- Severe valve disease
- Hypertrophic or dilated cardiomyopathy
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 |
|---|---|---|
| preoperative fastingFasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia | Behavioural | – |
Primary outcome
TAPSE volume
Time frame: 6 month
TAPSE, which is the right ventricular systolic function value, decreases after fasting, which is desired before the surgery
1 secondary outcome
fasting RV function
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Undecided. study protocol and statistical analysis available to other researchers
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Driving Pressure Optimization, RV-PA Coupling, and AKI in Mechanically Ventilated Critically Ill Patients
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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.
Aydin Maternity and Child Health Hospital
Aydin, Turkey (Türkiye)
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 TAPSE, run by Aydin Maternity and Child Health Hospital 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TAPSE volume (time frame: 6 month). 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 30 Jan 2023.