Upload
agatha-juniar
View
225
Download
0
Embed Size (px)
Citation preview
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 1/32
SOS BAKRI
TAMPONADEBALLOON
CATHETER
The Simple Solution for Postpartum Hemorrhage
Illustration by Lisa Clark
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 2/32
SOS Bakri Tamponade BalloonCatheter
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 3/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Contents
• Discussion• Introduction
• Indications
• Steps for Balloon Application
• Comparison to Existing ManualTreatments
• References
• Support Info
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 4/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Discussion
• Postpartum hemorrhage (PPH) is
defined as bleeding that occurs
immediately after the placenta is
delivered.• PPH remains in the top five causes of
maternal death in both developed and
developing countries.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 5/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Discussion
• PPH is an emergent situation. The
decision for appropriate treatment must
be made in a matter of minutes.
• Patients with PPH can deteriorate veryquickly.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 6/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Discussion
• Estimates of the incidence of PPHrange from as few as 1:100 to asfrequent as 1:20.
• The indications for use of the SOS BakriBalloon Catheter are for temporarymanagement of lower uterine segmentbleeding.Indicated in about one third of all PPHcases.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 7/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Introduction
• Various management measures areutilized for control of bleeding.
– Uterotonics
– Packing – Manual Compression
– Embolization
– Hysterectomy
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 8/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Introduction
• The ideal choice for managing apatient’s postpartum hemorrhage:
– Easily administered and removed.
– Control of capillary/venous bleeding and
surface oozing.
– Ability to gauge success of treatment in real
time.
– Avoid hysterectomy to preserve the
patient’s reproductive potential.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 9/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Introduction
• The SOS Bakri Tamponade Balloon byCook Ob/Gyn:
– Easily administered
– Quickly ascertain effectiveness.
– Able to gauge ongoing blood-loss through
inner lumen.
– Removes easily without need for separate
surgical procedure.
– Conservatively manages hemorrhage.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 10/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Indications
• The SOS Bakri Balloon catheter isintended to provide temporary control or
reduction of postpartum uterine
bleeding when conservative
management is warranted.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 11/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Indications
• While the device is intended as atemporary means of establishing
hemostasis in cases indicating
conservative management of
postpartum uterine bleeding, theapplication of this device should be
concomitant with close monitoring for
signs of arterial bleeding, atony
bleeding, and/or disseminated
intravascular coagulation (DIC).
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 12/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Contraindications
• The use of this product iscontraindicated in the presence of:
– Arterial bleeding requiring surgical
exploration or angiographic
embolization.
– Uterine atony bleeding.
– Cases indicating hysterectomy.
– Pregnancy
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 13/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Contraindications (cont.)
• The use of this product iscontraindicated in the presence of:
– Cervical cancer
– Purulent infections of the vagina,cervix, or uterus.
– Untreated uterine anomaly.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 14/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Contraindications (cont.)
• The use of this product iscontraindicated in the presence of:
– Disseminated intravascular
coagulation.
– A surgical site which would prohibit
the device from effectively controlling
bleeding.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 15/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Vaginal Delivery -- TransvaginalPlacement:
– Determine uterus is clear of any retained
placental fragments, arterial bleeding, or
lacerations. – Determine approximate uterine volume by
ultrasound or direct examination.
– Insert the balloon portion of the catheter in
the uterus, making certain that the entireballoon is inserted past the cervical canal
and internal ostium, under ultrasound
guidance.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 16/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Vaginal Delivery -- TransvaginalPlacement (cont.):Note: Avoid excessive force when insertingthe balloon into the uterus.
–If not already indwelling, place a Foleycatheter in patient bladder to collect andmonitor urine output.
–To ensure maintenance of correctplacement and maximize tamponade effect,
the vaginal canal may be packed withiodine or antibiotic soaked vaginal gauze atthis time.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 17/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Cesarean Delivery -- TransabdominalPlacement:
– Determine uterus is clear of any retained
placental fragments, arterial bleeding, or
lacerations.
– Determine uterine volume by intraoperative
direct examination or postoperative
ultrasound examination.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 18/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Cesarean Delivery -- TransabdominalPlacement (cont.):
– From above (via access of the Cesarean
incision), pass the tamponade balloon,
inflation port first, through the uterus and
cervix.
– Have an assistant pull the shaft of the
balloon through the vaginal canal, until the
deflated balloon base comes in contact with
the internal cervical ostium.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 19/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Cesarean Delivery -- TransabdominalPlacement (cont.):
–Close the incision by normal procedure,
taking care to avoid puncturing the balloon
while suturing.
–If not already indwelling, place a Foley
catheter in patient bladder to collect and
monitor urine output.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 20/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Cesarean Delivery -- TransabdominalPlacement (cont.):
–To ensure maintenance of correct
placement and maximize tamponade effect,
the vaginal canal may be packed with iodine
or antibiotic soaked vaginal gauze at this
time.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 21/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Instructions for Balloon Inflation
• Note: Always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide, or any other gas.
• Note: Do not over-inflate the balloon. Please refer to product label for maximum inflation volume.
– Ensure that indwelling Foley is placed in patientbladder at this time.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 22/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Instructions for Balloon Inflation(cont.) – To ensure that the balloon is filled to the desired
volume, it is recommended that the predetermined
volume of fluid be placed in a separate container,
rather than solely relying on a syringe count to verifythe amount of fluid that has been instilled into the
balloon.
– Using the enclosed syringe, begin filling the balloon
to the predetermined volume through the stopcock.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 23/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Instructions for Balloon Inflation(cont.) – Apply gentle traction to the balloon shaft to ensure
proper contact between the balloon and tissue
surface. To maintain tension, secure the balloon
shaft to the patient’s leg or attach to a weight, not toexceed 500 grams.
• Note: If balloon becomes dislodged due to shaft
tension and cervical dilation, deflate, reposition, and
re-inflate. Use of vaginal packing may be indicated
at that time to aid in balloon placement.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 24/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Patient Monitoring – Once balloon is placed and is inflated, connect thedrainage port to a fluid collection bag to monitor hemostasis.
• IMPORTANT: To adequately monitor hemostasis, the balloon drainage port andtubing should be flushed clear of clots withsterile isotonic saline. – Patient should be monitored continuously for signs
of increased bleeding, uterine cramping, or adeteriorating condition.
– Patient monitoring should include, but not be limitedto: Blood pressure, pulse, urine output, cramping,pallor, and active bleeding.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 25/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Patient Monitoring (cont.) • IMPORTANT: Signs of deteriorating or
non-improving conditions should indicate
more aggressive treatment and
management of patient uterine bleeding.
• IMPORTANT: This device is not a
substitute for surgical management and
fluid resuscitation of life-threatening
postpartum hemorrhage.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 26/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Application
Balloon Removal• Maximum indwell time is twenty-four (24)hours. Balloon may be removed sooner upon physician determination of hemostasis or need to apply moreaggressive treatment.
– Remove tension from balloon shaft.
– Remove any vaginal packing.
– Using an appropriate syringe, aspirate the contentsof the balloon until fully deflated.
– Gently retract the balloon from the uterus and
vaginal canal and discard. – Continue to monitor the patient for signs of uterine
bleeding.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 27/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Comparison
Bakri Balloon • Bakri balloon comes packagedwith syringe, and stores likeother surgical tools.
• May be applied quickly andeasily.
• Open inner lumen allows for direct measurement of ongoingblood loss.
• Silastic balloon conforms touterine cavity decreasing chanceof uterine trauma.
• Can be removed quickly withoutadditional invasive procedure.
Uterine Packing• Nominal Material Cost
• Possible concealed hemorrhage
• No record of blood loss
• Potential uterine trauma during
application.• Removal post-treatment can
require an additional trip to OR.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 28/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Comparison
Foley Catheters • Inexpensive, but are generally
ineffective in a large, postpartumuterine cavity.
• The application of multiple Foleysis cumbersome and less effective
than the Bakri Balloon. – If applied individually without an
overbag, Foleys do not readilyconform to uterine anatomy.
– Foley’s applied jointly in a plasticcovering or overbag, do not allowfor proper drainage, and canconceal uterine hemorrhage.
• Contains latex
• Not indicated for management of PPH.
Sengstaken-Blakemore Balloon• This is a naso-gastric balloon for
tamponade of esophagealvaricoceles and the introduction of contrast media.
• Does not necessarily take uterine
shape.• Expensive
• Contains latex
• Not indicated for management of PPH.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 29/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
SOS Bakri Tamponade
Balloon Catheter
• 100% Silicon (no latex)• Ductile shape allows it to conform to uterine anatomy
and shape.
• It allows for hemostatic cushion application, and limitsclot adhesion.
• The large diameter lumen in the shaft and multi-ported,non-abrasive tip allows for constant drainage, so anongoing uterine hemorrhage does not go undetectedpost-application
• Once deflated the Bakri Balloon is easily removed trans-vaginally without the need for an additional surgical
procedure.• Approved by the FDA for specific application to
postpartum hemorrhage.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 30/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Primary References
• Bakri YN, et al. Tamponade-balloon for
obstetrical bleeding. Int. J. Gynecol. Obstet.
2001; 74: 139-42.
• G. S. Condous, et al. The “Tamponade
Test” in the Management of MassivePostpartum Hemorrhage. Obstetrics and
Gynecology (2003) vol. 101, no. 4:767-772.
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 31/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Support
• FDA 510K Cleared:
– #K013597
– Tamponade Uterine Balloon Catheter Set
– Regulation number: 21 CFR 884.4530
– Regulation Name: Obstetric-gynecologicspecialized manual instrument
– Class: II
– Product Code: 85 KNA
– Approval Date: March 6, 2002 – Order Number: J-SOS-100500
7/28/2019 3. Sosbakri Langkah Baku
http://slidepdf.com/reader/full/3-sosbakri-langkah-baku 32/32
COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter
Contact
COOK® Medical Incorporated750 Daniels Way, P.O. Box 4195
Bloomington, IN 47402-4195 U.S.A.
Phone: 812 339-2235
Toll Free: 800 541-5591
Toll Free Fax: 800 837-4130
www.cookmedical.com