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Trial registered on ANZCTR


Registration number
ACTRN12618001067268
Ethics application status
Approved
Date submitted
13/06/2018
Date registered
26/06/2018
Date last updated
26/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Relationship Between Spinal Anesthesia-Related Hypotension and Ultrasonography of Internal Juguler Vein in Cesarean Section
Scientific title
The Relationship Between Spinal Anesthesia-Related Hypotension and Ultrasonography of Internal Juguler Vein in Cesarean Section
Secondary ID [1] 295200 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal anesthesia 308339 0
Condition category
Condition code
Anaesthesiology 307341 307341 0 0
Other anaesthesiology
Reproductive Health and Childbirth 307342 307342 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Hours
Description of intervention(s) / exposure
73 term pregnant women, older than 18 years undergoing elective cesarean section with spinal anesthesia were included the study. The exclusion criteria were high risk pregnancies who had chronic hypertension, preeclampsia, gestational diabetes, preterm pregnancy, pre-pregnancy obesity, or history of pregnancy complication and severe medical conditions such as pulmonary, liver and kidney disease.
The women was then transferred to the operating theatre. Non-invasive blood pressure and heart rate was applied with the woman in the supine position with an estimated 15° left lateral table tilt to avoid aortocaval compression by the uterus. After a stabilisation interval of 3–5 min, baseline systolic blood pressure (SBP) and mean blood pressure (MBP) were recorded. We used the non-invasive oscillometric method. After measurements, the antero-posterior internal jugular vein (IJV) diameter was measured using M-mode during a respiratory cycle. In order to avoid changes in vein diameter unrelated to respiratory variation, gentle pressure by the Ultrasonograhy (USG) probe was used to collapse the IJV in order to distinguish it from the carotid artery, then the pressure was relieved to the USG probe-skin interface and attention was given to avoid influence of probe compression on IJV dimensions during the USG examination. Moreover, in order to avoid interference of probeto- vein angle, the IJV evaluation was performed by positioning the probe perpendicular to the skin and oriented orthogonally to the IJV short-axis diameter. Ultrasound measurements of IJV diameter with respiration, which include maximum diameter of the IJV (dIJVmax) at the end of expiration during spontaneous respiration and collapsibility index (CI), have been recorded. The IJV CI (%) was calculated as CI = (dIJVmax – dIJVmin)/dIJVmax and was expressed as percentage. All measurements were made by a single author to eliminate interobserver variability.
Episodes of hypotension in the period after spinal anesthesia were defined by a more than 20% decrease in SBP from the baseline level or any recorded period of MBP lower than 60 mmHg. The MBP reading before IJV USG was defined as baseline.
The duration of observation of each participant was 2 hour.
Intervention code [1] 301538 0
Early Detection / Screening
Comparator / control treatment
Patients divided two groups who developed hypotension and did not develop hypotension after spinal anesthesia.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306295 0
spinal anesthesia-related hypotension
This outcome is assessed with data-linkage to medical records
Timepoint [1] 306295 0
1 hour post spinal anesthesia
Primary outcome [2] 306296 0
CI of IJV
This outcome is assessed with ultrasound
Timepoint [2] 306296 0
1 hour post spinal anesthesia
Primary outcome [3] 306341 0
dIJVmax
This outcome is assessed with ultrasound
Timepoint [3] 306341 0
1 hour post spinal anesthesia
Secondary outcome [1] 348098 0
Demographic characteristics (age, height, weight, and gestational age, heart rate)
This outcome is assessed with data-linkage to medical records
Timepoint [1] 348098 0
1 hour post spinal anesthesia
Secondary outcome [2] 348231 0
amount of crystalloid intraoperatively
This outcome is assessed with data-linkage to medical records
Timepoint [2] 348231 0
1 hour post spinal anesthesia

Eligibility
Key inclusion criteria
- 18 years older
- elective cesarean section under spinal anesthesia
- whose physical status is consistent with ASA II class
-gestational age must be >37 weeks

Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-neurological disease
-preeclampsia, diabetes mellitus, infection on the surgical site,
-disorders associated with bleeding/ clotting, severe agitation,
-non-cooperation, rejection of regional anesthesia,
- known fetal abnormality, placenta previa, history of ablatio placentae, risk for growth retardation and meconium aspiration; pathology that may affect the acid-base balance, antepartum hemorrhage,
- severe medical conditions such as pulmonary, liver and kidney disease.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Shapiro Wilk test was used as normality test. Continuous variables were compared using Student t-test and Mann-Whitney U test when the data were not normally distributed. Categorical variables were compared using Pearson’s chi-squared test and Fisher’s exact test. Paired data were analyzed using Paired t-test and Wilcoxon signed rank test when data were not normally distributed. For responses at different time points, percent changes were calculated according to baseline measurement. These percent changes were compared using Mann-Whitney U test for two groups and Kruskal Wallis test more than two groups. Correlations between variables were tested using Pearson and Spearman correlation coefficients. A p-value <0.05 was considered as significant. All statistical analyses were performed with IBM SPSS ver. 23.0.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10560 0
Turkey
State/province [1] 10560 0
Bursa

Funding & Sponsors
Funding source category [1] 299785 0
Self funded/Unfunded
Name [1] 299785 0
Derya Karasu
Address [1] 299785 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [1] 299785 0
Turkey
Primary sponsor type
Individual
Name
Derya Karasu
Address
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country
Turkey
Secondary sponsor category [1] 299132 0
Individual
Name [1] 299132 0
Cagdas Baytar
Address [1] 299132 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [1] 299132 0
Turkey
Secondary sponsor category [2] 299134 0
Individual
Name [2] 299134 0
Canan yilmaz
Address [2] 299134 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa

Country [2] 299134 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300673 0
Uludag University Clinical Research Ethics Committee
Ethics committee address [1] 300673 0
Gorukle Campus 16059 Nilufer/BURSA
Ethics committee country [1] 300673 0
Turkey
Date submitted for ethics approval [1] 300673 0
Approval date [1] 300673 0
28/03/2017
Ethics approval number [1] 300673 0

Summary
Brief summary
Background:it has been shown that sonographic determination of the diameter of the inferior vena cava (IVC) is related to central venous pressure and other hemodynamic parameters describing the patient’s volume status. IVC measurements are not possible in 10-15% of patients because of large body size, excessive bowel gas, or large amounts of intrathoracic air. Since internal jugular vein (IJV) imaging does not require transthoracic echocardiography and is technically easier to perform than IVC visualization at pregnant women. This study investigated whether preoperative ultrasound IJV measurements could predict hypotension after spinal anesthesia in pregnant patients undergoing cesarean section.
Methods:A prospective, observational study carried out in patients undergoing cesarean section. In 73 patients, older than 18 years and scheduled for elective cesarean section with spinal anesthesia were included in the study. Maximum diameter of the IJV (dIJVmax) and collapsibility index (CI) were measured preoperatively before spinal anesthesia. Hypotension was defined by a more than 20% decrease in systolic blood pressure from the baseline level or any recorded period of mean blood pressure lower than 60 mmHg.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84422 0
Mrs Derya Karasu
Address 84422 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 84422 0
Turkey
Phone 84422 0
+905057281175
Fax 84422 0
Email 84422 0
drderyatopuz@gmail.com
Contact person for public queries
Name 84423 0
Mrs Canan Yilmaz
Address 84423 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 84423 0
Turkey
Phone 84423 0
+905059045989
Fax 84423 0
Email 84423 0
dr_cnnylmz@yahoo.com
Contact person for scientific queries
Name 84424 0
Mr Cagdas Baytar
Address 84424 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 84424 0
Turkey
Phone 84424 0
+905542255960
Fax 84424 0
Email 84424 0
cagdasbaytar31@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary