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CHHS16/186 Canberra Hospital and Health Services Operational Procedure Use of the L-Dex U400 Bioelectrical Impedance Spectroscopy (BIS) Device for adults with unilateral lymphoedema Contents Contents..................................................... 1 Purpose...................................................... 2 Alerts....................................................... 2 Scope........................................................ 2 Section 1 – Arm Measurement..................................2 Section 2 – Leg Measurement..................................4 Implementation............................................... 5 Related Policies, Procedures, Guidelines and Legislation.....6 References................................................... 6 Definition of Terms..........................................6 Search Terms................................................. 7 Attachments.................................................. 7 Attachment A – Bioimpedance Calvary Competency Document.....8 Attachment B – CHHS Bioelectical Impedance Spectroscopy Competency Document........................................10 Doc Number Version Issued Review Date Area Responsible Page CHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute Support 1 of 15 Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Page 1: Use of the L-Dex U400 Bioelectrical Impedance … · Web viewPregnancy – although the use of bioelectrical impedance technology in pregnant patients has been shown to have no adverse

CHHS16/186

Canberra Hospital and Health ServicesOperational Procedure Use of the L-Dex U400 Bioelectrical Impedance Spectroscopy (BIS) Device for adults with unilateral lymphoedemaContents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Alerts.........................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Arm Measurement.................................................................................................2

Section 2 – Leg Measurement...................................................................................................4

Implementation........................................................................................................................ 5

Related Policies, Procedures, Guidelines and Legislation.........................................................6

References................................................................................................................................ 6

Definition of Terms...................................................................................................................6

Search Terms............................................................................................................................ 7

Attachments..............................................................................................................................7

Attachment A – Bioimpedance Calvary Competency Document..........................................8

Attachment B – CHHS Bioelectical Impedance Spectroscopy Competency Document.......10

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support1 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Purpose

To provide lymphoedema therapists working across Canberra Hospital and Health Services (CHHS) with an operational procedure on the safe and effective use of the L-Dex U400 Bioelectrical Impedance Spectroscopy (BIS) Device on patients with unilateral limb lymphoedema.

Scope

Alerts

Contraindications Patients with cardiac pacemakers

Precautions Pregnancy – although the use of bioelectrical impedance technology in pregnant

patients has been shown to have no adverse effects the L-Dex U400 has not yet been clinically validated for use within this population group (Ritsuko Y et al 2003)

The device should not be operated in the presence of strong electromagnetic fields

Scope

This operational procedure pertains to the following adult patient types only: Women with or at risk of developing unilateral arm or leg lymphoedema Men with or at risk of developing unilateral leg lymphoedema

This document pertains to any lymphoedema therapist using the L-Dex U400 as part of a lymphoedema assessment across CHHS locations.

The L-Dex U400 is a bioelectrical impedance analyser which uses impedance ratios to support the measurement of extracellular fluid volume differences between the limbs.

Section 1 – Arm Measurement

Equipment L-Dex U400 BIS Device Lead Set Alligator clips Stylus pen Alcohol Swabs Self-adhesive skin electrodes

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support2 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

This Standard Operating Procedure (SOP) describes for staff the process to

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Procedure 1. Explain the procedure and gain and document consent from the patient2. Ask the patient to remove all jewellery (rings on fingers may be left on)3. Ask the patient to remove socks/stockings4. Advise the patient that they should have an empty bladder5. Document if the patient has exercised or had caffeine two hours prior to the reading or

alcohol 12 hours prior to the assessment as this may affect the reading6. Ask the patient to lie in a supine position with their arms by their side, hands resting next

to their body, palms down. Ensure there is no skin to skin contact of the patient's legs7. Gently rub skin sites for electrode placement with an alcohol wipe and shave areas if

needed to achieve good skin contact8. Apply electrodes adhesive side down:

a. 2cm proximal to the ulna styloid at the midline of the wrist bilaterally (Fig. 2)b. Mid way through the third metacarpal bilaterally (Fig. 2)c. Mid way between the medial and lateral malleolus of the right foot (Fig. 2)d. Mid way through base of the metatarsals of the right foot (Fig. 2)

Figure 2. Electrode placement for arm measurements

9. Switch the device on, enter the patient details and the at risk arm10. Connect the leads to the device ensuring that the colour of the lead ends match the

colour of the connector at the back of the device 11. Attach an alligator clip to the probe end of each of the four leads12. Ensure the leads are not tangled and attach the alligator clip to each electrode as

directed by the prompts on the device a. Initial measurement is taken of the right arm; yellow lead attaches to proximal

electrode right wrist, red lead attaches to distal electrode on right hand, blue lead attaches to proximal electrode of left wrist, black lead attaches to distal electrode on right foot

13. Press ‘Measure’ on the display screen of the device. If happy with the raw data press ‘Accept’ on the display screen (the raw data graph should be represented in a semicircular pattern)

14. Press ‘Next Measurement’ on the display screen of the device and follow the prompts for the lead connectiona. The second measurement is taken of the left arm; yellow lead attaches to proximal

electrode at left wrist, red lead attached to distal electrode of left hand, blue lead attached to the proximal electrode on right wrist, black lead attaches to distal electrode on right foot

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support3 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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15. Press ‘Measure’ on the display screen of the device. If happy with the raw data press ‘Accept’ on the display screen (the raw data graph should be represented in a semicircular pattern)

16. The Measurement Results screen will now be displayed with the L-Dex reading. Record this in the patient's notes

17. Disconnect the alligator clips from the electrodes and remove the electrodes from the patients skin

Back to Table of Contents

Section 2 – Leg Measurement

Equipment L-Dex U400 BIS Device Lead Set Alligator clips Stylus pen Alcohol Swabs Self-adhesive skin electrodes

Procedure 1. Explain the procedure and gain and document consent from the patient2. Ask the patient to remove all jewellery (rings on fingers may be left on)3. Ask the patient to remove socks/stockings4. Advise the patient that they should have an empty bladder5. Document if the patient has exercised or had caffeine two hours prior to the reading or

alcohol 12 hours prior to the assessment as this may affect the reading6. Ask the patient to lie in a supine position with their arms by their side, hands resting next

to their body, palms down. Ensure there is no skin to skin contact of the patient's legs7. Gently rub skin sites for electrode placement with an alcohol wipe and shave areas if

needed to achieve good skin contact8. Apply electrodes adhesive side down:

a. 2cm proximal to the ulna styloid at the midline of the right wrist (Fig. 3)b. Mid way through the third metacarpal of the right wrist (Fig. 3)c. Mid way between the medial and lateral malleoli on the leg bilaterally (Fig. 3)d. Mid way through base of the metatarsals on the feet bilaterally (Fig. 3)

Figure 3. Electrode placement for leg measurement

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support4 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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9. Switch the device on, enter the patient details and the at risk leg10. Connect the leads to the device ensuring that the colour of the lead ends match the

colour of the connector at the back of the device 11. Attach an alligator clip to the probe end of each of the four leads12. Ensure the leads are not tangled and attach the alligator clip to each electrode as

directed by the prompts on the device a. Initial measurement is taken of the right leg; yellow lead attaches to proximal

electrode on the left ankle, red lead attaches to distal electrode on right hand, blue lead attaches to proximal electrode of right ankle, black lead attaches to distal electrode on right foot

13. Press ‘Measure’ on the display screen of the device. If happy with the raw data press ‘Accept’ on the display screen (the raw data graph should be represented in a semicircular pattern)

14. Press ‘Next Measurement’ on the display screen of the device and follow the prompts for the lead connectiona. The second measurement is taken of the left leg; yellow lead attaches to proximal

electrode at right ankle, red lead attached to distal electrode of right hand, blue lead attached to the proximal electrode on left ankle, black lead attaches to distal electrode on left foot

15. Press ‘Measure’ on the display screen of the device. If happy with the raw data press ‘Accept’ on the display screen (the raw data graph should be represented in a semicircular pattern)

16. The Measurement Results screen will now be displayed with a lymphoedema index (L-Dex value). Record this in the patient's notes

17. Disconnect the alligator clips from the electrodes and remove the electrodes from the patient's skin

Back to Table of Contents

ImplementationAll lymphoedema therapists working across CHHS are credentialed and carry out an L-Dex measurement according to this operational procedure

This will be achieved via: Inclusion of this operational procedure in orientation for new staff working in the area

of lymphoedema Credentialing of lymphoedema staff according to appropriate competency assessment

tool (Attachments 1 and 2) Relevant HP4 or HP3 staff providing individual feedback to relevant staff regarding

compliance via documentation audits and peer review Regular communication at monthly Lymphoedema HUB meetings if issues arise

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support5 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Back to Table of Contents

Related Policies, Procedures, Guidelines and Legislation

Credentialing and Defining the Scope of Clinical Practice for Allied Health ProfessionalsConsent to Treatment PolicyStandards of Practice for ACT Allied Health ProfessionalsL-Dex U400 Bioelectrical Impedance Spectroscopy Device Instruction Manual

Back to Table of Contents

References

1. Bunce IH, Mirolo BR, Hennessey JM. Post-mastectomy lymphoedema treatment and measurement (1994). Medical Journal Australia 161:125-128

2. Cornish BH, Bunce IH, Ward LC. Bioelectrical impedance for monitoring the efficiency of lymphoedema treatment programmes (1996). Breast Cancer Research Treatment 38:169-176

3. Hayes S, Cornish B, Newman B. Comparison of methods to diagnose lymphoedema among breast cancer survivors: 6-month follow-up (2005). Breast Cancer Research Treatment 89:221-226

4. Ritsuko Y. Bioelectrical impedance analysis in the clinical management of preclamptic women with oedema (2003). Journal Perinatal Medicine 31:275-280

5. Ward LC, Dylke E, Czerniec S, Isenring E, Kilbreath SL. Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphoedema by bioelectrical impedance spectroscopy (2011). Lymphatic Research & Biology 9(1):47-51

6. Ward LC, Dylke E, Czerniec S, Isenring E, Kilbreath SL. Reference ranges for assessment of unilateral lymphoedema in legs by bioelectrical impedance spectroscopy (2011). Lymphatic Research & Biology 9(1):43-46

Back to Table of Contents

Definition of Terms

L-Dex value: The L-Dex value is derived from the ratio of the impedance determined for the unaffected limb and the at-risk or affected limb. The normal ranges are between -10 to +10 (Ward et al 2011). L-Dex values greater than 10 may indicate the early signs of lymphoedema and values that have changed +10 L-Dex units from baseline may also indicate early lymphoedema (Ward et al 2011)

Back to Table of Contents

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support6 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Search Terms

Lymphoedema, Bioimpedance, L-Dex

Back to Table of Contents

Attachments

Attachment A – Bioimpedance Calvary Competency DocumentAttachment B – CHHS – Bioelectical Impedance Spectroscopy Competency Document

Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Service specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Date Amended Section Amended Approved By

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

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Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Attachment A – Bioimpedance Calvary Competency Document

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support8 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support9 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

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Attachment B – CHHS Bioelectical Impedance Spectroscopy Competency Document

Doc Number Version Issued Review Date Area Responsible PageCHHS16/186 1 12/10/2016 01/10/2021 Medicine – Acute

Support10 of 10

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register