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Indian Pediatr 2021;58:643-646 |
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Agreement
Between Non-Invasive (Oscillatory) and Invasive
Intra-Arterial Blood Pressure in the Pediatric
Cardiac Critical Care Unit
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Amit Kumar,1 Jigar P
Thacker, 1 Manoj Chaudhary,1
Ajay G Phatak,2 Somashekhar M Nimbalkar1
From Department of 1Pediatrics, Pramukhswami
Medical College; and 2Central Research Services,
Charutar Arogya Mandal; Karamsad, Anand, Gujarat.
Correspondence to: Dr Jigar P Thacker,
Assistant Professor, Department of Pediatrics,
Pramukhswami Medical College, Shree Krishna
Hospital, Karamsad 388 325, Anand, Gujarat.
Email:
thackerjigar@yahoo.co.in
Received: July 24, 2020;
Initial review: August 21, 2020;
Accepted: December 16, 2020.
Published online: March 26, 2021;
PII: S097475591600307
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Objective: We assessed the agreement between
non-invasive (oscillatory) blood pressure (NIBP)
measurements and invasive intra-arterial blood
pressure (IBP) in the pediatric cardiac critical
care unit. Methods: Children with
intra-arterial lines as per standard management
protocol were enrolled. NIBP was measured every
4 hourly and the corresponding IBP reading was
recorded. Results: A total of 839
brachial NIBP, 834 IBP femoral (IF), and 137 IBP
radial (IR) readings were noted on 45
participants. The mean difference (95% CI) for
agreement between NIBP and IF was -2.3 (-27.1,
22.5) mmHg for systolic, 0.9 (-21.3, 23.1) mmHg
for diastolic and 0.3 (-23.3, 23.9) mmHg for
mean BP. Similar results were found between NIBP
and IR and between IF and IR. The interrater
agreement [Kappa (95% CI)] was fair between NIBP
and IF [0.54 (0.48, 0.61)], and IF and IR [0.62
(0.48, 0.76)] but lower between NIBP and IR
[0.37(0.20, 0.55)] when values were classified
as hypotensive, normotensive, and hypertensive.
Conclusions: NIBP cannot replace but can
supplement IBP in the pediatric cardiac critical
care setting.
Keywords: Accuracy,
Comparison, Indirect blood pressure, Femoral
blood pressure.
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Blood pressure (BP) recording is an integral
part of hemodynamic monitoring for quick therapeutic
decisions in an intensive care setting. Non-invasive
BP (NIBP) monitoring by an oscillatory automated
device is an accepted modality in most clinical
settings. Alternatively, invasive monitoring after
placing an intra-arterial catheter is considered the
gold standard as it provides continuous, reliable,
and beat to beat monitoring of the BP [1,2].
Invasive BP (IBP) monitoring is the norm in
pediatric post-cardiac surgery settings [3]. The
NIBP measurement is affected by multiple factors
including accuracy of the equipment, observer bias,
position and movement of the arm, and the child’s
cooperation [4]. Determination of the appropriate BP
cuff size is also crucial in pediatric patients. IBP
reading is affected by movement artifact, altered
pulse traveling in case of arterial dissection or
stenosis, calibration errors, or overdamping and
under-damping phenomena due to inappropriate dynamic
response of the fluid-filled monitoring systems [5].
It is technically cumbersome and requires trained
manpower to insert and maintain an arterial
catheter, which may not be readily available at all
facilities. IBP monitoring systems have known
complications such as local tissue injury, excessive
bleeding, hematoma for-mation, blood-stream
infection, thrombosis or embolism, distal ischemia,
and pseudoaneurysms of the vessels [6].
NIBP is easy, cost-effective, and
avoids potential harms caused by invasive arterial
line. Several studies have compared the accuracy of
NIBP to IBP in intensive clinical care settings
[3,7,8]. There are fewer such studies in the
pediatric cardiac critical care setting [3]. This
observational study assessed the agreement between
NIBP by an automated oscillatory method with IBP in
the pediatric cardiac critical care setting.
METHODS
This study was conducted in the
pediatric cardiac critical care unit on
post-operative patients who had undergone
cardiothoracic surgeries. As per the protocol of the
unit, the patient was induced on a radial arterial
line by the anesthetic team in an operating room.
Later, central venous and femoral arterial lines
were inserted. Hemo-dynamics in the intra-operative
and post-operative period were monitored via the
femoral line. The radial line was not preferred for
the peri-operative monitoring, parti-cularly for the
surgeries involving cardio-pulmonary by-pass and was
less stable in the pediatric age group due to
frequent de-lining. The study was approved by the
institu-tional ethics committed with a waiver of
informed consent.
All consecutive patients with an
intra-arterial line (radial and/or femoral) were
selected for this study. The decision of placing an
arterial line was made by the treating team. All
lines were placed without ultrasound guidance.
Radial and femoral lines used in the same patient
were connected to the same transducer via a
three-way stopcock. The radial line was usually
removed on the next day of surgery, whereas the
femoral line was kept as long as required. NIBP
measurement was done by the oscillatory method
within one hour of admission to the post-operative
care unit and then repeated every four hourly.
Patients with contraindications to NIBP cuff
application/inflation (arm injuries or wounds, limb
edema) were excluded from the study. Patients with
uncorrected or inadequately corrected coarctation/interruption
of aorta were also excluded. IBP reading was
concurrently noted at each instance of NIBP
recording in a patient. Age, weight, height, primary
diagnosis, type of surgery/intervention, and current
clinical condition of all participants were
recorded.
IBP measurement was performed
with an appro-priately sized arterial catheter
(Leader-Flex, Vygon, GmbH & Co) inserted into the
radial/femoral artery and connected to a disposable
pressure transducer (iPeX, B L Lifesciences Pvt Ltd)
using rigid pressure tubing of identical length. In
neonates, a 24 G cannula (Jelco) was used to obtain
a radial line. The transducer was connected to the
blood pressure module of the Drager, Infinity Vista
XL (Dragerwerk AG & Co) bedside monitor. The
catheter was flushed with heparinized saline (2
units/mL) at the rate of 3 mL/hour to prevent
clotting. However, in neonates, the rate of flow was
kept at 1 mL/hour via syringe pump to reduce their
fluid intake. As both radial and femoral lines were
connected to the same transducer by a three-way
stopcock, the flush was entering one arterial line
at a time. The IBP measurements were documented
every hour by rotating the valve. Four hourly IBP
values for invasive femoral (IF) and invasive radial
(IR) were taken to coincide with the NIBP
measurements. The pressure monitoring set had a
continuous flush element pigtail that could be
pulled to allow the rapid flush of the system. The
transducer position was at the level of the
patient’s 4th intercostal space at the mid-axillary
line, ensuring the absence of kinking or air bubbles
in the tubing and transducer. Zeroing and fast-flush
test to verify optimal damping was done in every
nursing shift. Oscillatory BP (NIBP) in the upper
limb was measured by using Drager, NIBP cuff (Dragerwerk
AG & Co) of appropriate sizes and connected to the
BP module of the Drager, Infinity Vista XL – Multi-para
monitor via BP cable. The NIBP was measured in a
different limb to that with the arterial line.
The blood pressure measurements
by all the three methods were classified as
hypotensive, normotensive, and hypertensive based on
age and height by systolic value [9-11]. Fifth
percentile cut off was used to label hypotension in
our patient population [9].
Statistical analysis:
Bland-Altman analysis was performed to assess
agreement amongst NIBP, invasive femoral (IF), and
invasive radial (IR) recordings. Kappa statistic
with quadratic weights was used to assess agreement
amongst the three methods at a crude level. The
analysis was performed using STATA 14.2.
RESULTS
During a period of nine months, a
total of 45 (33 male) patients [median (IQR) age 12
(4,84) months] were enrolled in the study. A total
of 839 upper limb NIBP measurements, 834 femoral
line, and 137 radial line blood pressure readings
were available. The primary diagnosis and age group
of the patients are mentioned in Table I. All
the patients were on ventilatory and inotropic
support during the initial post-operative period.
The median (Q1,Q3) duration for ventilatory and
inotropic support was 36 (7,74) and 57 (24,80)
hours, respectively. None of the patients had
pre-existing hypertension or features of vasculitis.
The mean difference (95% CI) for agreement between
NIBP and IF line was -2.3 (-27.1, 22.5) mm Hg for
systolic, 0.9 (-21.3, 23.1) mmHg for diastolic and
0.3 (-23.3, 23.9) mm Hg for mean blood pressure.
The mean difference (95% CI) for agreement
between NIBP and IR line was -0.5 (-23.2, 22.3) mmHg
for systolic, 2.1 (-19.6, 23.8) mmHg for diastolic
and 2.3 (-19.1, 23.6) mmHg for mean blood pressure.
The agreement between IF and IR line had a mean
difference (95% CI) 0.3 (-21.5, 22.2) mm Hg for
systolic, -0.6 (-15.8, 14.7) mmHg for diastolic and
0.7 (-13.7, 15.1) mm Hg for mean blood pressure.
Table I Age Group and the Primary Diagnosis of the Patients (N=45)
Characteristics |
No. (%) |
Age |
|
<1 mo |
7 (15) |
1-12 mo |
20 (44) |
1-5 y |
5 (11) |
5-10 y |
7 (15) |
10-18 y |
6 (13) |
Diagnosisa |
|
Ventricular septal defect |
10 (22) |
Atrial septal defect |
9 (20) |
Tetrology of fallot |
8 (18) |
Total anomalous
pulmonary venous return |
4 (09) |
Double outlet right
ventricle |
4 (09) |
aPatent
ductus arteriosis and transposistion of
great arteries in two children each; and
anomalous origin of left coronary artery
from pulmonary artery, atrio-ventricular
canal, coarctation of aorta, single right
ventricle, tricuspid atresia, severe mitral
regurgitation were seen in one child each. |
The inter-rater agreement [Kappa
with quadratic weights (95% CI)] for readings
classified as hypotensive, normotensive, or
hypertensive was fair between NIBP and IF [0.54
(0.48, 0.61)] and between IF and IR [0.62 (0.48,
0.76)] but slightly lower between NIBP and IR
[0.37(0.20, 0.55)]. IF and IR classified 109/133
(81.2%) records correctly (6 hypotensive, 89
normotensive, 14 hypertensive). The correct
classification between NIBP and IF and IR is shown
in Table II.
Table II Agreement in Classification of Blood Pressure by NIBP and IBP
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Invasive femoral |
Invasive radial |
Hypotensive |
14/37 |
6/7 |
Normotensive |
558/649 |
90/109 |
Hypertensive |
103/147 |
5/20 |
Numerator denotes values agreed by NIBP
and IBP and denominator denotes values by
NIBP alone; IBP: invasive arterial blood
pressure; NIBP: non-invasive blood pressure. |
DISCUSSION
The mean difference between NIBP
and IBP among systolic, diastolic, and mean BP
readings were marginal in the present study but wide
95% confidence limits made both these methods
non-comparable and irreplaceable.
NIBP gave lower readings for
systolic and higher for diastolic in comparison with
both IF or IR as expected norms [1] but with a
minimal difference, unlike wide mean difference
reported earlier [8]. Higher systolic readings with
NIBP were seen in few studies [3,12]. As per our
unit policy of placing the femoral line for better
stability, NIBP was compared against both invasive
femoral (IF) and invasive radial (IR) unlike studies
which compared radial lines only [5,7,8]. Both
brachial NIBP and femoral IBP in this study
represent central BP, unlike, radial readings which
represents peripheral BP [8]. Physiologically, a
slightly elevated lower limb BP reading than the
upper limb is expected. The present study did not
find significant difference between upper limb (NIBP
or IR) and lower limb (IF) blood pressure, as also
seen in a similar study [3].
IBP should be preferentially used
when patient is hemodynamically stable or deviations
can be detrimental in setting like pediatric cardiac
intensive care [13]. Invasive and non-invasive
(oscillatory) methods have entirely different
principles. IBP monitoring has a column of fluid
connecting an arterial catheter to a pressure
transducer [1,7]. Oscillatory devices track
oscillations of the pressure in a cuff during its
progressive deflation. The maximal oscillation
corresponds to MAP and systolic and diastolic
readings are calculated which results in different
accuracy with different devices [7]. Improper cuff
size and poor cooperation and movement of the
pediatric subject can affect NIBP reading [4].
Though the mean difference
between IF and IR readings was insignificant, a wide
range existed among; systolic, diastolic, and mean
BP. Invasive measurements give different values
depending upon the site of measurement [7,14] and
state of shock where peripheral radial pressure
value may not accurate [14].
Clinically significant
discrepancies in systolic blood pressure values can
be present between invasive and oscillometric
non-invasive methods during hypotension [2]. Outside
the normotensive range, the automated readings were
higher during hypotension and lower during
hypertension compared to the arterial BP [15].
However, such specific trends were not seen in this
study. IBP reading is affected by underdamping/resonance
phenomena in a significant number of events where
NIBP measurement along with IBP is beneficial [5]. A
clinician should remain cautious and check for the
accuracy of both the instruments if in doubt; before
undertaking any treatment [7]. Thus, the use of NIBP
along with IBP results in lower use of vasopressors,
transfusions, and antihypertensive when compared
with IBP alone [16].
There are certain limitations to
the study. This study enrolled participants from
neonatal age to 18 years, representing diverse body
mass and stature. The agreement between NIBP and IBP
in age and height related subgroups was not assessed
due to the small sample size. Almost all the
patients were on inotropic support during the
initial post-operative period, which might have
affected the actual representation of BP readings.
We could not separate the readings in the presence
and absence of shock (compensated or
non-compensated).
To conclude, the agreement
between NIBP and Invasive BP readings was not
optimal, while inter-rater agreement was fair for
different categories of blood pressure. Considering
IBP monitoring as the gold standard in the pediatric
post-cardiac surgical setting, it cannot be replaced
with NIBP, but rather should supplement with NIBP
when in doubt.
Ethics clearance:
Institutional ethics committee; No IEC/
HMPCMCE/114/Faculty/11/ dated October 1, 2019.
Conside-ring the nature of the study, a waiver of
informed consent was approved.
Contributors: JT:
conceptualized and designed the study, guided and
supervise data collection, drafted the manuscript,
and approved the final manuscript; SN:
conceptualized and designed the study, critical
review of the manuscript, and approved the final
manuscript; AK; critical inputs for design of the
study and manuscript preparation, drafting the
manuscript, guided and supervise data collection,
and approved the final manuscript; MC; helped in
study planning and execution, continued onsite data
collection and interpretation, and approved the
final manuscript; AP: conceptualized and designed
the study, data analysis, critical input for
manuscript preparation, and approved the final
manuscript.
Funding: None;
Competing interest: None stated.
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WHAT THIS STUDY ADDS?
•
Non-invasive blood pressure measurement
should supplement intra-arterial blood
pressure measurement in pediatric cardiac
critical care settings.
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