UNIVERSITAS INDONESIA

EFFECT OF LATERAL TILT ANGLE ON THE VOLUME OF

THE ABDOMINAL AORTA AND INFERIOR VENA CAVA IN
PREGNANT AND NONPREGNANT WOMEN DETERMINATED
BY MAGNETIC RESONANCE IMAGING

Hideyuki Higuchi, M.D., Shunichi Takagi, M.D., Kan Zhang, M.D., Ikue
Furui, M.D., Makoto Ozaki, M.D.

CRITICAL APPRAISAL

THOMAS AQUINAS SYUKUR REJO TONDA

1006767260

DEPARTEMEN ANESTESI DAN TERAPI INTENSIF

FAKULTAS KEDOKTERAN UNIVERSITAS INDONESIA

NOVEMBER 2015
 HALAMAN PENGESAHAN

Critical Appraisal ini diajukan oleh :

Nama : Thomas Aquinas Syukur Rejo Tonda
NPM : 1006767260
Program Studi : Anestesiologi dan Terapi Intensif
Judul Jurnal : Effect of Lateral Tilt Angle on the Volume
of the Abdominal Aorta and Inferior
Vena Cava in Pregnant and Nonpregnant
Women Determined by Magnetic
Resonance Imaging

Telah diterima sebagai bagian persyaratan yang diperlukan untuk

memperoleh gelar Dokter Spesialis pada Program Studi Anestesiologi
dan Terapi Intensif, Fakultas Kedokteran, Universitas Indonesia

Pembimbing : dr Alfan Mahdi SpAn-K

Ditetapkan di : Jakarta
Tanggal : November 2015
CRITICAL APPRAISAL

Effect of Lateral Tilt Angle on the Volume of the Abdominal Aorta and Inferior
Vena Cava in Pregnant and Nonpregnant Women Determined by Magnetic
Resonance Imaging

Hideyuki Higuchi, M.D., Shunichi Takagi, M.D., Kan Zhang, M.D., Ikue Furui, M.D.,
Makoto Ozaki, M.D.
General
1. Is the clinical question clearly defined? Yes
Patient : Pregnant healthy women with cephalic singleton pregnancies
at full term (37–39 weeks’ gestation) and nonpregnant healthy
female volunteers.
Intervention : Positioning the patient at supine and left-lateral tilt position
(15°, 30°, and 45°)
Comparison : Non pregnant healthy female.
Outcome(s) : Aortic and IVC volumes
2. What is the clinical question evaluating
How long the changes in pregnant woman position can change the aorta and
IVC volumes that morfologicaly observed by MRI
3. What was the study design? Not stated, but implicitly the study design is non
randomized, observer-blinded, Control trial.
4. Was there a clearly focused clinical question and primary hypothesis?
Yes. Left-lateral tilt position is used to reduce assumed aortocaval compression
by the pregnant uterus in the supine position.
5. Are there any declare conflict of interest that may bias the result of the
study? No. The authors declare no competing interests.
Methodology
Population
1. What was the sampling method? Not mentioned but implicitly by
stratification.
2. Were the inclusion/ exclusion criteria clearly defined? Yes
The inclusion criteria: healthy women with cephalic singleton pregnancies at
full term (37–39 weeks’ gestation) and nonpregnant healthy female volunteers.
The exclusion criteria: Women with obesity (body mass index > 30),
cardiovascular disease such as hypertension (systolic blood pressure > 140
mmHg), a known fetal abnormality, and those women who were unable to lie
in the supine position in the MRI
3. Did the sample include a representative spectrum of subject? Yes
4. How was the sample size determined?
Sample size calculation was based on a preliminary study. Power analysis (α =
0.05, β = 0.20) indicated that a subject sample size of 11 per group was needed
to reveal a significant difference in the IVC volume of supine pregnant women
compared to those in the left-lateral tilt position at 30°, assuming that the
difference in the IVC volume between the two points was 8.0 ml ± 4 (mean ±
SD)
5. Do the authors explain how selection bias was minimized? No. But
implicitly by Restriction in inclusion and exclusion criteria.
6. Was allocation of subject to intervention and control groups concealed
from the researchers? No

Confounders
1. Were the intervention group and control group similar at the start of the
study? Yes.
2. Were the group treated equally except for the receipt of intervention? Yes
3. How were patient allocated to the treatment and control groups?
Pregnancy was confirmed by ultrasound and report of last menstruation.
 Nonpregnant women had negative pregnancy test results and reported
menstruation in the previous 4 weeks.
4. Were either the researchers or subjects blinded to the treatment? Yes.
Images were encoded and randomized to blind the investigator to the object of
the current study and the source of the image with regard to pregnancy.
5. Was the blinding process clearly explained? Yes
6. Was the adequate placebo used in the controlled group? No
7. Were the clinical endpoints measured clearly stated? Yes
8. How was the clinical endpoint measured ?
One of the authors (S.T.) determined the areas of the aorta and IVC from the
L1–L2 disk level to the L3–L4 disk level for each axial MRI image using the
public domain Osirix Imaging Software 5.8.5 (developed by Pixmeo, Bermex,
Switzerland).* The images were encoded and randomized to blind the
investigator to the object of the current study and the source of the image with
regard to pregnancy. The area of the axial section was each multiplied by the
interval between slices (2.3 mm) to calculate aortic and IVC volumes from
the L1–L2 disk level to the L3–L4 disk level.

Reliability And Validity

1. Was a valid measurement of the clinical endpoint made? Yes
2. Were the endpoints assessed using validated measuring methods/
instruments? Yes
3. Is there evidence provided for the reliability of the measuring instruments/
methods used? No
4. Was training and standardization used to improve the consistency of
measurements made? No
5. Was follow up complete and sufficient duration? Yes
6. Has an appropriate methods of statistical analysis been chosen? Data are
expressed and analyzed using an unpaired test where appropriate. Inter- and
intragroup comparisons were analyzed using a two-way repeated analysis of
 variance measure followed by the Dunnett post hoc test for multiple comparison.
A P value of less than 0.05 was considered statistically significant (two-tailed).
7. How many groups were compared? Two groups

Result
1. Was the study analyzed using an intention to treat analysis? Not Stated
2. How precise was the estimate of the treatment effect? The left-lateral tilt
position was supported by a 1.5-m-long hard V-block constructed of closed-cell
polyethylene foam that extended from head to toe under the right side of the
subject’s body. It was visually confirmed that the right side of the subject’s body
was properly positioned on the foam, the angle of the body was not assessed
directly using a protractor. The subjects were first positioned supine, then at 15°,
30°, and 45° in order.
Applicability
1. Are your patients similar to target population? Yes
2. Were all the relevant outcome measures considered? Yes
3. Will the intervention help your patient population? Yes
4. Are the benefits of the intervention worth the risks and costs? No
5. Have the patient values and prefenrences been considered? Yes