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420
Key Questions in CONGENITAL CARDIAC SURGERY
g) consider changing faulty components.
Pump failure:
a) call for help from the PICU, surgical and perfusion teams; b) ventilate conventionally to support the respiratory system; c) haemodynamic support with inotropes and vasoconstrictor
agents;
d) if there is no flow, consider the risk of thrombus formation
whilst the ECMO is not working;
e) if pump head failure is the cause, use the back-up console,
battery and check the wall power;
f) if an electrical issue is the cause, clamp the lines and turn off the
pump, commence hand cranking and evaluate the integrity of the pump head. Consider changing the pump head, turning the pump to the minimal settings of 1000-1500 rpm, remove the clamps, and then gradually increase the rpm. Check for thrombus;
g) if pump head failure is the cause, clamp the lines and stop the
pump, replace the pump head, turn the pump to the minimal settings of 1000-1500 rpm, remove the clamps, and then gradually increase the rpm. Check for thrombus.
Cardiac arrest on VV ECMO:
a) call for help; b) CPR; c) consider and check for reversible causes; d) DC shock if in shockable rhythm.
Cardiac arrest on VA ECMO. Cardiac arrest has little effect on
ECMO support, if flows are maintained:
a) call for help; b) DC shock if in shockable rhythm.
Accidental decannulation. On VV ECMO, it may be accompanied by
profound hypoxia, hypovolaemic shock and cardiac arrest, whereas VA ECMO may be accompanied by cardiac arrest and hypovolaemic shock:
a) call for help; b) clamp the circuit; c) turn off the pump; d) commence cardiopulmonary resuscitation;
11 Extracorporeal membrane oxygenation
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e) ventilate; f) administer volume and cardiovascular support; g) prepare for surgical intervention.
Air in the circuit. Air can find its way through various ports,
connections, as well as faults in the circuit and cannulae. The presence of a significant amount of air will compromise ECMO flows and performance:
a) clamp the arterial line; b) stop the pump; c) place the patient in a head-down position; d) commence inotropic and ventilatory support, including volume
replacement; e) examine possible entry points and call for help, if required.
Circuit rupture, which is accompanied by massive blood loss, air
entry to the circuit, and haemodynamic and respiratory compromise:
a) clamp the circuit; b) stop the pump; c) call for help; d) support the cardiovascular and respiratory systems; e) replace volume lost; f) prepare for surgical intervention if required or change all or
parts of the circuit.
Thrombus in the circuit. Although this is the most common
complication, meticulous management of anticoagulation can help to reduce the risk. Some small-size thrombi may cause problems with the ECMO support. Thrombi of any size pose a danger when present in the outflow portion of the circuit but less so when in the inlet portion, unless large, as they will end up in the oxygenator. Management involves maintaining an optimal ACT, monitoring the circuit for thrombus, and if required, clean or change the affected component of the circuit
33 Describe the steps when stopping and recommencing
extracorporeal membrane oxygenation
In a circuit with a roller head pump:
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a) clamp the venous line above the bridge; b) open the bridge clamp;
Key Questions in CONGENITAL CARDIAC SURGERY
c) clamp the arterial line above the bridge; d) stop the flow.
To return to ECMO flow:
a) open the arterial clamp; b) clamp the bridge; c) open the venous cannula; d) return to the previous pump head speed (rpm).
In a circuit with a centrifugal pump:
a) close the post-oxygenator clamp; b) clamp the venous line above the bridge; c) open the bridge; d) clamp the arterial line; e) release the post-oxygenator clamp; f) maintain ECMO flow through the bridge.
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To return to ECMO flow:
a) close the post-oxygenator clamp; b) clamp the bridge; c) open the arterial clamp; d) open the venous clamp; e) increase the pump head speed (rpm); f) remove the post-oxygenator clamp; g) clear the bridge.
34 What are the general parameter guidelines for
paediatric extracorporeal membrane oxygenation support?
ACT 160-220 seconds.
PaO260-80mmHg (VA), 45-80mmHg (VV).
Haemoglobin 13-15g/dL (VA), 15g/dL (VV).
Haematocrit >40 (VA), >45 (VV).
pH 7.35-7.45.
PaCO235-45mmHg.
Platelet count >75 x 109/L.
Urine output >2mL/kg/hour.
Heparin 25-50 units/kg/hour (but may need to be adjusted according
to renal function, bleeding and the presence of a haemofilter).
11 Extracorporeal membrane oxygenation
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Venous O2saturation 70-75%.
Fluid requirements 20-100mL/kg/day (<10kg 100mL, 10-20kg
50mL, and >20kg 20mL). Calorie requirements 60-90/kg/day.
Maintain serum sodium, potassium and calcium levels at normal
values. VA ECMO flow 100mL/kg/min x 0.8 (80% of estimated cardiac
output). VV ECMO flow 80-120mL/kg/min (but may need to be adjusted
according to the recirculation flow and the effective flow).
35 Describe the steps when commencing extracorporeal
membrane oxygenation
After completing the cannulation process, check the circuit, including
the position of the cannulae and the patient, ensuring that the cannulae are secure. Open the clamp on the venous line above the bridge.
Close the clamp on the bridge.
Open the clamp on the arterial line above the bridge.
Slowly increase the blood flow.
Monitor the cardiovascular response.
Wean off the ventilation support.
Wean off the inotropic support.
Re-evaluate the circuit for the presence of air bubbles.
Check all the connections and ports.
Check that the console, transducers and all other electrical
components are operational. Perform the calculations regarding flow, sweep, FiO2, drug and fluid
infusions. Check the ACT or APTT and adjust heparin, as appropriate.
Optimise the clotting profile.
Inform all personnel involved about the set parameters and alarms.
Recheck that the cannulae are secure.
Request an echocardiogram and chest radiograph, as appropriate.
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36 What are the principles of daily management for a
patient requiring extracorporeal membrane oxygenation?
Daily routine checks and evaluation of all the organ systems are
crucial not only for optimal support but also for survival.
424
Key Questions in CONGENITAL CARDIAC SURGERY
It is important to regularly check the cannulation site, cannulae and
circuit (mechanical and electrical components). Ensure that the position of the patient’s head is in the midline, up to 30°. Cardiovascular system:
a) maintain systemic perfusion and intravascular volume; b) monitor urine output, central venous pressure, physical signs
of perfusion, and body weight; c) use echocardiography, as required; d) check the circuit for the presence of clots and overall integrity; e) regular ECG and relevant blood tests.
Respiratory system:
a) ventilation settings; b) evaluate arterial blood gases and chest radiograph; c) avoid build-up of secretions in the endotracheal tube and
pulmonary hygiene with flexible bronchoscopy, as required.
Renal system:
a) in the first 48 hours, there is a high incidence of acute tubular
necrosis and oliguria. Thereafter, the urine output usually
increases to >2mL/kg/hr; b) if renal function does not improve, however, renal support can
be added to the circuit with continuous renal replacement
therapy (CRRT); c) a renal blood test may be required daily, according to function.
Central nervous system (CNS):
a) avoid paralytic agents; b) perform regular sedation holding and neurologic examinations,
including pupil size and reaction, reflexes, level of
consciousness, and the presence of normal or abnormal
movements; c) a head US or CT may be required, although CT requires
transporting the patient to the radiology department on ECMO.
Infection control:
a) all procedures and interventions should follow aseptic
techniques;
11 Extracorporeal membrane oxygenation
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b) check all sites for infection; c) send appropriate cultures of blood, sputum and urine; d) antibiotics, as indicated.
Fluids, electrolytes and nutrition:
a) regular monitoring of electrolytes, including magnesium,
calcium and phosphorus levels;
b) close monitoring of fluid balance, high calorie intake and
nutritional support, as required.
The surgical team should perform daily checks of the cannulation
site, cannulae, circuit, assist in dressing changes, be available to transport the patient, and be available to perform any invasive procedure.
Recommended reading
1. Brogan TV, Lequier L, Lorusso R, MacLaren G, Peek G.
qÜÉ= bipl= oÉÇ= _ççâ
(ELSO); 2017.
2. Short BL, Williams L.
Support Organization (ELSO); 2010.
3. Pappalardo F, Montisci A. What is extracorporeal cardiopulmonary resuscitation?
qÜçê~Å=aáë
4. Schmidt M, Pellegrino V, Combes A, Scheinkestel C, Cooper DJ, Hodgson C.
Mechanical ventilation during extracorporeal membrane oxygenation.
18(1): 203.
5. Barbaro RP, Guner Y. Pediatric Extracorporeal Life Support Organization Registry
International Report 2016.
6. Yam N, McMullan DM. Extracorporeal cardiopulmonary resuscitation.
2017; 5(4): 72.
7. Chan T, Thiagarajan RR, Frank D, Bratton SL. Survival after extracorporeal
cardiopulmonary resuscitation in infants and children with heart disease.
`~кЗбзо~лЕ=pмкЦ
8. Kane DA, Thiagarajan RR, Wypij D, Scheurer MA, Fynn-Thompson F, Emani S, del
Nido PJ, Betit P, Laussen PC. Rapid-response extracorporeal membrane oxygenation
to support cardiopulmonary resuscitation in children with cardiac disease.
2010; 122(11 Suppl): S241-8.
9. Extracorporeal Life Support Organization. Guidelines for ECMO centres, training and
continuous education. Available at http://www.elso.org. Accessed 26.02.21.
2017; 9(6): 1415-9.
, 5th ed. MI, USA: Extracorporeal Life Support Organization
b`jl=pйЙЕб~дблн=qк~бебеЦ=j~ем~д
^p^fl=g
2008; 136(4): 984-92.
2017; 63(4): 456-63.
bснк~ЕзкйзкЙ~д=iбСЙ=pмййзкнW
. MI, USA: Extracorporeal Life
`êáí=`~êÉ
^åå=qê~åëä=jÉÇ
2014;
g= qÜçê~Å
`бкЕмд~нбзе
425
g
426
Key Questions in CONGENITAL CARDIAC SURGERY
10. Trummer G, Foerster K, Buckberg GD, Benk C, Mader I, Heilmann C, Liakopoulos
O, Beyersdorf F. Superior neurologic recovery after 15 minutes of normothermic
cardiac arrest using an extracorporeal life support system for optimized blood
pressure and flow.
11. Booth KL, Roth SJ, Thiagarajan RR, Almodovar MC, del Nido PJ, Laussen PC.
Extracorporeal membrane oxygenation support of the Fontan and bidirectional Glenn
circulations.
12. Makdisi G, Wang I. Extracorporeal membrane oxygenation (ECMO) review of a
lifesaving technology.
13. Rood KL, Teele SA, Barrett CS, Salvin JW, Rycus PT, Fynn-Thompson F, Laussen
PC, Thiagarajan RR. Extracorporeal membrane oxygenation support after the Fontan
operation.
14. Gomez D, Duffy V, Hersey D, Backes C, Rycus P, McConnell P, Voss J, Galantowicz
M, Cua CL. Extracorporeal membrane oxygenation outcomes after the comprehensive
stage II procedure in patients with single ventricles.
15. Conrad SA, Rycus PT. Extracorporeal membrane oxygenation for refractory cardiac
arrest.
^åå=`~êÇ=^å~ÉëíÜ
16. Khorsandi M, Davidson M, Bouamra O, McLean A, MacArthur K, Torrance I, Wylie G,
Peng E, Danton M. Extracorporeal membrane oxygenation in pediatric cardiac
surgery: a retrospective review of trends and outcomes in Scotland.
`~кЗбзд
2018; 11(1): 3-11.
17. Gupta P, Robertson MJ, Beam B, Gossett JM, Schmitz ML, Carroll CL, Edwards JD,
Fortenberry JD, Butt W. Relationship of ECMO duration with outcomes after pediatric
cardiac surgery: a multi-institutional analysis.
18. Balasubramanian SK, Tiruvoipati R, Amin M, Aabideen KK, Peek GJ, Sosnowski AW,
Firmin RK. Factors influencing the outcome of paediatric cardiac surgical patients
during extracorporeal circulatory support.
mЙкСмлбзе
^åå=qÜçê~Å=pìêÖ
2014; 29(2): 130-8.
2004; 77(4): 1341-8.
g=qÜçê~Å=aáë
g=qЬзк~Е=`~кЗбзо~лЕ=pмкЦ
2017; 20(Supplement): S4-10.
2015; 7(7): E166-76.
2011; 142(3): 504-10.
^êíáÑ=lêÖ~åë
jбеЙко~=^еЙлнЬЙлбзд
g=`~кЗбзнЬзк~Е=pмкЦ=
2017; 41(1): 66-70.
^åå= mÉÇá~íê
2015; 81: 619-27.
2007; 2: 4.
Chapter 12
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Informed consent in congenital cardiac surgery
Robert A. Wheeler
1 What is the role of consent in modern society?
Choice has achieved a high priority in our society.
Citizens’ choices in education, transport structure and healthcare
provision, to name a few, are constantly and publically acknowledged. The necessity for choice reflects the fundamental role of autonomy:
the right of every citizen to influence their own destiny. In this context, the need to choose to accept (consent) the otherwise
unwanted physical contact of any type (touch) is self-evident. In fact, unwelcome attentions from another person who tries to touch you against your wishes are considered repellent. There are times when certain contacts or touches are unavoidable,
such as in packed trains, shops and sidewalks. In some cases, there is little choice but to resign yourself to being touched. But in any less frenetic circumstances, there is an absolute
understanding that we are entitled to choose who touches us, and when.
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2 Why is consent necessary in health care?
One important consequence of the need for consent is that a patient,
or their parent, must agree in advance of physical touching, before any intervention can ensue. The teenage patient, who is lying on his or her hospital bed, when
suddenly confronted with a surgeon who puts his or her hand on the apex beat without first asking for permission, would justifiably complain that the treatment fell below the reasonable standard one would be entitled to expect. Clearly, such behaviour is simple rudeness, irrespective of the legal context. However, the legal context is suddenly placed into stark relief when
a patient complains that an intimate examination was performed without consent; and further still when such an examination was irrelevant to his or her clinical presentation.
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Key Questions in CONGENITAL CARDIAC SURGERY
These latter actions move the lack of consent into the arena of
professional disciplinary regulation, as well as civil litigation and potentially criminal prosecution. Several medical defence organisations’ case reports are a testament to this not infrequent and devastating error of judgement. Plainly, interventions required in congenital cardiac surgery are more
complex and threatening than the simple touch. But the need for consent, based on disclosure as to what is entailed and why it is necessary, is built upon this elementary foundation.
3 Is consent needed for anything other than treatment
interventions?
In paediatric cardiac surgery, the patient or parent must agree, in
advance, before any of the confidential information that they impart when dealing with their surgeon can be further disclosed. Clearly, it is consent for surgical intervention that is uppermost on the
surgeon’s mind, and rightly so. But the rules of consent encompassing aspects of care, such as
competence or capacity, correct disclosure and appropriate recording, are equally applicable to both clinical interventions and to confidentiality. Consent is the legal key that makes both physical intervention and
sharing of information lawful.
4 What is a child, under English law?
From the legal perspective, a child is someone who has not yet
reached 18 years of age. Legal synonyms include ‘minor’ and ‘infant’. The latter is instructive, since it is derived from the Latin,
áåÑ~åë
, unable to speak. This reflects the legal rule preventing children from speaking for
themselves in court, although this impediment has been at least partly addressed over the last two decades. Nevertheless, this definition begs a fundamental question; as to
whether children can provide their own consent, or whether they depend upon their parents to provide it for them.
5 What is a ‘young person’ under English law?
It is becoming more common in England to describe citizens of 16
and 17 years as ‘young people’. This acknowledges that they are still children from the legal perspective, whilst at the same time accepting
12 Informed consent in congenital cardiac surgery
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that as they approach majority, their autonomy is emerging, reflected by certain legal rights. For instance, the Mental Capacity Act 2005 applies to those who are
16 years and over, prescribing measures to be taken if they lack capacity. Nevertheless, those with parental responsibility for young people
retain parallel rights to consent on their behalf, although these rights diminish as the child achieves competence or capacity.
6 What is a ‘looked after child’ under English Law?
Children are described as being ‘looked after’ by the local authority
(LA) when either:
a) they have been made the subject of a care order by a family
court, which obliges the local authority to look after the child;
b) the local authority provides the child with accommodation, in
the absence of a care order.
In both cases, the child’s local authority passport, generally provided
by the foster parent should make clear into which category the child falls. Clearly, children who are a subject of a care order will usually also be accommodated by the local authority. The existence of the care order is of great importance, since it directs
the local authority to share parental responsibility for the child with the parent(s), who before the start of the order had parental responsibility for the child. Since only those with parental responsibility for the child can provide consent for his or her treatment, it is vital to ascertain which adults hold parental responsibility. If no care order is in place, consent needs to be sought from the
parents. If an order is in place, the local authority passport will indicate
whether the local authority has restricted the scope of the birth parents’ parental responsibility. If they continue to bear parental responsibility for medical decisions, they can provide consent. If the local authority appears to have restricted the parents from giving consent, advice should be sought.
7 Who can provide consent for surgery?
A person with parental responsibility has the right to provide consent
where necessary. The child’s mother (the woman who gave birth to the baby, but not the person who provided the egg from which
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