3. sosbakri langkah baku

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SOS BAKRI

TAMPONADEBALLOON

CATHETER

The Simple Solution for Postpartum Hemorrhage

Illustration by Lisa Clark



SOS Bakri Tamponade BalloonCatheter



COOK® Ob/GynSOS Bakri Tamponade Balloon Catheter

Contents

• Discussion• Introduction

• Indications

• Steps for Balloon Application

• Comparison to Existing ManualTreatments

• References

• Support Info




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.




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.




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.




Introduction

• Various management measures areutilized for control of bleeding.

– Uterotonics

– Packing – Manual Compression

– Embolization

– Hysterectomy




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.




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.




Indications

• The SOS Bakri Balloon catheter isintended to provide temporary control or

reduction of postpartum uterine

bleeding when conservative

management is warranted.




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).




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




Contraindications (cont.)


– Cervical cancer

– Purulent infections of the vagina,cervix, or uterus.

– Untreated uterine anomaly.




Contraindications (cont.)


– Disseminated intravascular

coagulation.

– A surgical site which would prohibit

the device from effectively controlling

bleeding.




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.




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.




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.




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.




Application


–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.




Application


–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.




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.




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.




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.




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.




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.




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.




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.




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.




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.




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.




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




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

3. sosbakri langkah baku

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