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A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
• Use a tongue depressor/throat swab to gently poke the membrane
lateral to the midline.
• Repeat on both sides of the midline.
Interpretation:
• Presence of brain stem function: Soft palate elevates and tongue depresses.
• Absence of brain stem function: No response
Brain Stem Death Determination Process Flowchart
Dr Gopi Ayyaswamy
Rule 4(3) (a) and (b) of the THO Rules 1995-Form 8 gives the Guidelines
for Apnoea Tests: Patient should have a temperature of more than
35° centigrade euvolemic and with systolic pressure ≥90 mm of Hg.
I. Therstapnoeatestshouldbeperformedonlyafter4hoursofcoma
associatedwithabsenceofbrainstemreexes.Inthecaseofanoxic
braindamage,thisperiodshouldbeextendedto12hours.
II. The physician involved in certifying brain stem death shall be
present during ventilator removal to attest the presence of apnoea
if found.
III. Ventilator manipulation is performed to raise the PaCO
2
≥40 mmHg.
IV. Thepatientshould behyperoxygenatedwith 100%oxygenfor
15 minutes, while still on the ventilator, prior to the apnoea test.
V. Either a blood gas or trending of ETCO
2
should be used to determine
the adequacy of the baseline prior to the test. SPO
2
should be
monitored during apnoea test.
VI. Placethepatienton100%oxygenthroughatrachealcatheterwiththe
tip towards the end of the tube with a continuous 6 L/min O
2
ow.
VII. The patient is taken off the ventilator in the presence of the physician
certifying brain stem death. The patient is kept off the ventilator for
a variable period of time (usually 3 to 8 minutes) to allow the PaCO
2
to rise ≥55 mmHg or ≥15 mmHg over baseline. During this time the
patient is observed for respiratory movements.
Apnoea Test Protocols
17
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A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
Apnoea Test Interpretations
a. Positive Test: Implying apnoea despite adequate stimulation
• Patient remains apnoeic, without respiratory movements
• PaCO
2
is ≥55 mmHg or ≥15 mmHg from baseline
b. Negative Test: Implying apnoea is not present
Respiratory efforts noted at any time during the test
c. Indeterminate Test
• PaCO
2
<55 mm Hg or there is less than 15 mm Hg increase over baseline.
• Indeterminate tests can either be repeated or another conrmatory
test utilized.
Note: Apnoea test should be aborted if the patient develops hypotension, or signicant cardiac
arrhythmias. These norms will vary for patients less than 12 years and patients with major chest trauma.
Conditions for Confirmatory/Ancillary Testing
If parts of the neurological examination or apnoea test cannot be performed
for any reason or if the results are indeterminate at any step, conrmatory
or ancillary tests should be done. Some of the situations that may demand
conrmatory testing include:
i. Severe facial trauma that avoids the consultant from performing the
neurological examination/apnoea test.
ii. Pre-existing papillary abnormalities
iii. Toxic blood levels of sedatives, depressants, drugs or poisons.
iv. Sleep apnoea or severe pulmonary disease contributing to chronic
retention of CO
2
List of conrmatory/ancillary tests in the order of the most sensitive
test rst.
i. Conventional angiography
ii. Electroencephalography
iii. Trans cranial Doppler ultrasonography
iv. Technetium
Apnoea Test Protocols
147
Dr Gopi Ayyaswamy
v. Hexamethyl propylene amine oxime (HMPAO), brain scan
vi. Somatosensory evoked potentials
Conventional Angiography
No intracerebral lling at the level of the carotid bifurcation or circle of
Willis. The external carotid circulation is patent, and lling of the superior
sagittal sinus may be delayed.
Electroencephalography
No electrical activity during at least 30 minutes of recording that adheres
to the minimal technical criteria for EEG recording in suspected brain
stem death as adopted by the American Electroencephalographic Society,
including 16-channel EEG instruments.
Transcranial Doppler Ultrasonography
1. Ten percent of patients may not have temporal insonation windows.
Therefore, the initial absence of Doppler signals cannot be interpreted
as consistent with brain stem death.
2. Small systolic peaks in early systole without diastolic flow or
reverberating ow, indicating very high vascular resistance associated
with greatly increased intracranial pressure.
Technetium-99m Hexamethyl Propyleneamineoxime Brain Scan
No uptake of isotope in brain parenchyma (“hollow skull phenomenon”).
Somatosensory Evoked Potentials
Bilateral absence of N20-P22 response with median nerve stimulation.
The recordings should adhere to the minimal technical criteria for
somatosensory evoked potential recording in suspected brain death as
adopted by the American Electroencephalographic Society.
Repeat Assessment
1. Usually, on completion of a conclusive neurological examination and
apnoea test, brain stem death is determined and no additional testing/
repeat assessment is necessary.
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A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
2. If the testing is not consistent with brain stem death, a repeat assessment
has to be conducted after an appropriate interval.
3. In the event of using conrmatory tests, a conclusive result of that specic
investigation can be followed with determination of brain stem death.
4. However, if the conrmatory testing is inconclusive, and repeat clinical
assessments cannot be done, the conrmatory test should be repeated
after 24 hours.
Note: Following an initial negative conrmatory test, if clinical examination can be done completely
and reliably to arrive conclusively at the diagnosis, then repeat conrmatory testing is not essential
Precautions
The following manifestations are occasionally seen and should not be
misinterpreted as evidence for brainstem function. The following issues
are compatible with the diagnosis of brain stem death.
1. Spontaneous movement of limbs other than pathologic flexion or
extension response.
2. Respiratory-like movements (shoulder elevation and adduction, back
arching intercostals expansion without signicant tidal volumes).
3. Sweating, blushing, tachycardia.
4. Normal blood pressure without pharmacologic support or sudden
increases in blood pressure.
5. Absence of diabetes insipidus.
6. Deep tendon reexes; supercial abdominal reexes; triple exion
response.
7. Babinski reex.
Steps to Be Followed When a Diagnosis for brain stem death is being
considered
1. Testing
• The rst tests to be done by the consultant of ICU unit.
• The second series of test to be done by two consultants of the
department, one of whom should be on the ofcially nominated panel.
• The second series to be done 6 hours after the rst.
Apnoea Test Protocols
149
Dr Gopi Ayyaswamy
2. Ensure that the following results are available (or at least have been
sent) at the conclusion of the rst series of tests
• Blood for hepatitis B surface antigen
• Blood for HIV
• Blood for HCV
• Blood for blood group analysis
• Blood for liver function tests
• Blood for WBC TC/DC
• Blood for PT, PTT and platelets
3. Inform transplant coordinator about possible candidate after rst positive
test.
Note: The protocol is to be aborted if the transplant team examines the candidate, enquires
about the candidate or talks to the candidate’s relatives before this.
4. The coordinator will
• Interact with family and keep the ICU informed at all times
• Inform all other personnel of the transplant team (it is not the
responsibility of the ICU to contact anyone other than the coordinator)
• Obtain all drugs and uids necessary for the patient once the rst
test is positive
• Complete all legal formalities except for lling Form 8
5. The time of death in all cases will be recorded as the time of the second
positive test.
Dr Gopi Ayyaswamy
Health & Family Welfare Department—Organ transplant—cadaver organ
transplant program—procedure to be adopted for cadaver transplant by
the government and private hospitals approved for organ transplant by
the appropriate authority—orders issued.
G.O. (Ms) No. 287 Dated: 05.09.2008, Annexure 6 of G.O. (Ms) No. 75 of
03.03.2008 states that: According to Form 8 of the said Act and Rules, when
such certication is required, there shall be two medical examinations
conducted by a team of doctors after a minimum interval of six hours and
the ndings made based on the tests prescribed therein.
A. Doctor No. 1 is the RMP. In charge of the hospital in which brain stem
death has occurred’. Accordingly, the Registered Medical Practitioner
in charge of the hospital in which brain stem death has occurred shall
refer to either the Head of the Institution, RMO, ARMO, Duty RMO or
the RMP in charge of the Hospital. (No clearances are required from
the appropriate authority in this category.)
B. Doctor No. 2 is the RMP (physicians, surgeons or intensivist) nominated
from the panel of names approved by the appropriate authority’.
Accordingly, a panel of names shall be sent by the Dean/Medical
Superintendent/Medical Director to the appropriate authority, namely
the Director of Medical and Rural Health Services and on approval shall
then be utilized as the panel from which a RMP shall be nominated
for each brain stem death certication. Each hospital may determine
its own procedure for this duty.
Brain Stem Death
Declaration Protocols
18
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A Simple Introduction to Organ Transplant
Dr Gopi Ayyaswamy
C. Doctor No. 3 is ‘neurologist/neuro-surgeon nominated from the panel
of names approved by the appropriate authority’. Again, a panel of
names shall be sent by the Dean/Medical Superintendent/Medical
Director to the appropriate authority, namely the Director of Medical
and Rural Health Services and on approval shall then be utilised as
the panel from which one specialist as in the category therein shall be
nominated for each brain stem death certication. Each hospital may
determine its own procedure for this duty. In the latest amendment
intensivists and anaesthesiologists have also been included in this
category
D. Doctor No. 4 is the RMP treating the aforesaid person. This does
not require any clarication and shall be the RMP/Doctor on duty
treating the patient. (No clearances are required from the appropriate
authority in this category.)
Note
i. In the event of lack of authorized personnel in Category 3 above in the hospital concerned, a
request may be made to any other member of the panel from another hospital.
ii. The 1st and 2nd Medical examination as dened in Form-8 of the THO rules shall be conducted
by category 2 and 3. Doctors from the panel approved by the Appropriate Authority.
Although it has been made mandatory for the three Medical College
hospitals in Chennai to follow this procedure, the same procedure shall
be applicable to all hospitals inclusive of private hospitals which wish
to certify brain stem death as and when required. Accordingly, the
categories that are required for the panel to be approved shall be done so
on submission to the appropriate authority (Director of Medical and Rural
Health Services).
Brain Stem Death Declaration Protocols
153
Dr Gopi Ayyaswamy
Sample
FORM 8
[See rule 4(3)(a) and (b) of the THO Rules 1995]
We, the following members of the Board of medical experts after
careful personal examination, hereby certify that Shri/Smt./Km.
aged about s/o, d/o, w/o, Shri.
resident of is dead on account of
permanent and irreversible cessation of all functions of the brain-stem.
The tests carried out by us and the ndings therein are recorded in the
brain-stem death Certicate annexed hereto.
Dated: Signature:
1. RMP, In charge of the hospital in which
brain-stem death has occurred
2. RMP, nominated from the panel of names
approved by the Appropriate Authority.
3. Neurologist/neuro-surgeon nominated
from the panel of names approved by the
Appropriate Authority.
4. RMP, treating the aforesaid deceased person.