Got droperidol?

If you’ve been following blogs such as THE PHARM recently, you’ll probably have seen reference to a chap called Minh le Cong and a drug called ketamine.  Now it’s no secret that many in the prehospital and emergency fields are fond of ketamine – it’s a useful dissociative agent with analgesic properties and can be given IM, IV or IN and used for analgesia, sedation and induction.

Like any drug it requires familiarity with use and titration to effect (although I prefer pre-drawn drugs for RSI, with doses based on IBW and haemodynamics).  I reckon that if I polled a roomful of doctors and asked them to give a dose of ketamine, many would be hesitant having not used it before.  Safe practice mandates familiarity with the drug and appropriate training and monitoring…

Sedation of the Acutely Agitated Patient – a High Risk Procedure

But there is an area of practice that has bugged me for some time, namely the management of an acutely agitated patient. This is a difficult situation – the patient is agitated and may be a risk to self and others. The staffing in a rural hospital is minimal – there is no ‘Code Black’ with security officers –  the team may involve an RN and EN initially, with the on-call doctor off site and taking some time to arrive.

Whilst a calm environment and de-escalation is ideal, sometimes situational urgency mandates use of agents to calm the patient. It’s all well and good if the patient is cooperative and insightful enough to take a dose of oral medication (typically olanzapine antipsychotic +/- oral diazepam)…but if not, they may require a rapid ‘takedown’ with IM or IV medication.

And this is a problem, as the agents commonly recommended by many Health Department protocols STILL include short-acting agents associated with profound respiratory depression.  Alternating cycles of extreme agitation, and administration of short- and long-acting agents can lead to increasing amounts being used and a slide into respiratory collapse.

Looking few various protocols from various sources can be confusing; there’s a wide variety in suggested agents – a quick search in an (unnamed) rural ED showed a variety of available protocols. This is potentially dangerous – in a crisis, the ‘occasional sedatonist’ is likely to seek some form of protocol..and yet may lack familiarity with the agents in use.

The Occasional Sedationist may be reassured by a protocol and lulled into a false sense of confidence in administering drugs without adequate backup

Many protocols seem to encourage polypharmacy, including the use of IV midazolam. Other agents in some of these protocols include ;

ORAL – olanzapine, diazepam, lorazepam, risperidone

IM – olanzapine, haloperidol, clonazepam, midazolam, lorazepam zuclopenthixol

IV – midazolam, diazepam, lorazepam

Even though there have been recent Coroner’s reports on deaths of such patients, a recent report failed to address the issue of safe sedation and instead focus on the need for more rapid transfer. Whilst I am in favour of rapid transport of patients requiring retrieval (not least because of the demands on staff in a resource-limited environment), it’s not the lack of a helicopter that kills these patients – it’s the cycle of agitation-sedation and cardiorespiratory collapse, occasionally exacerbated by restraint that is dangerous. Couple this with a general failure to approach the clinical situation with the same diligence as we would for providing procedural sedation in ED or OT, with it not unheard of for these patients to be nursed in a dark room, supervised by a mental health worker outside the door, with occasional recording of routine obs – scant appreciation of the fact that we are giving administering anaesthetic agents!

Moreover, many of the protocols available in EDs make vague reference to ‘safe environment’ without specifying the need for airway equipment, the use of ETCO2 to monitor nor airway or anaesthetic risk assessment.

Pertinent Coroners reports are here :

David Lee Coroners report

Lyji Vaggs Coroners report

Adam Fernandez Coroners report

 

Droperidol & ketamine – safer than short-acting benzos!

So the Twittersphere was abuzz today with the announcement of the DORM-2 study from Melbourne – a prospective observational study looking at the safety of droperidol for management of these patients.  Older readers may remember concerns from 15 years or so ago regarding droperidol and prolongation of the QTc causing torsade de pointes. The study demonstrated no prolongation of the QTc in the cohort studied, nor any incidences of torsades de pointes (a criticism is that this is relatively rare and would require a larger study). More importantly, the study demonstrated the effectiveness of droperidol in achieving a state of rousable sedation – the goal in this situation.

I think this is important. I use droperidol occasionally in theatre for both sedative and anti-emetic properties; it’s available in most hospital or can be ordered in.  And I think it’s a useful addition to the armamentarium. So much so that I’ve dropped haloperidol from my approach and will run with initial olanzapine where possible; if this fails, IM droperidol titrated to target sedation score.

Of course ketamine DOES also have a role; and I am a particular fan of it’s use for transport of such patients without the need for risking RSI in an unfasted patient with unproved airway (obesity, OSA and COPD are not uncommon in these patients, as are complications of intubation such as aspiration and the need for an ICU bed at the other end). There are protocols available for running ketamine infusions once initial sedation is achieved. I won’t reproduce them (for examples see here and here), but suggest that early consultation and advice from the retrieval service is mandatory…

Safe Sedation Guidelines 2015

Moreover, it helps bolster a rationale approach to sedation of the acutely agitated psychiatric patient – there’s been a bit written on this recently, with release of a Consensus Statement – The Acutely Agitated Patient in a Remote Location as well as a collaborative effort between some emergency and rural clinicians in Australia to guide practice in rural ED or on the wards.

We’ve termed it ‘Surviving Sedation Guidelines’ in recognition of the very real risks that use of these agents can pose.

Listen to a podcast here on the “aikido of emergency sedation” from Minh, Casey and myself

See also posts on Surviving Sedation Guidelines 2015 from the PHARM here, from BroomeDocs here and from KIDocs here

KEY PRINCIPLES OF SURVIVING SEDATION GUIDELINES

Early Goal Directed Sedation (EGDS) – titrated sedation to an objective level using a validated sedation scoring system

Consideration of emergency sedation as a form of procedural sedation/anaesthesia. 

 Minimum standards of patient assessment, resuscitation equipment and clinical monitoring 

De-emphasis on sedative drug choices with more emphasis on continuous clinical assessment and titration to effect

There is a lot more to psych sedation than just bunging in a dose of benzo and walking away…I’d encourage people to read the extensive notes on Minhs blog post regarding this, and consider the use of droperidol, as well as stalwarts olanzapine and diazepam in a stepwise approach titrated to a desired sedation level.

Other than oral diazepam, there is no mention of using short acting benzos such as midazolam…and I think this is a GOOD thing! See what you think….

An updated version of the guidelines is here: SSG2015 v6.0

 

Screen Shot 2015-04-18 at 5.39.00 pm

Screen Shot 2015-04-18 at 5.39.27 pm

Fine-tuning the partnership with ICU families

Hola a tod@s, my dear friends.

Today we want to share with you Involvement of ICU families in decisions: fine-tuning the partnership, a recent review of Dr. Elie Azoulay with open access in Annals of Intensive Care.

Families are not just visitors. They are in sudden grief for the loss of health and they must adapt to an unknown and intimidating atmosphere. They have anxiety (70%), depression (35%), stress (33%) and difficulty to understand information given to them (50%).

In this environment they are asked to take decisions about an ill family member. Therefore,the article encourages to discuss the fact of sharing decision-making with them.



The article reviews the theoretical models of doctor-patient relationship: from the paternalism of the 70´s to the autonomy of the 80´s, with their limitations and deficiencies, towards a model of shared decision-making by the three protagonists: patient, family and healthcare professionals.

In addition, they propose and explain ten key points to improve family care in the ICU.



A very interesting article with practical application, as we enjoy, and that many questions will arise. You can send them as comments, and we generate the necessary debate trying to connect with the authors.

Happy Saturday,
Gabi

AirXpanders Completes Enrollment in XPAND US Pivotal Trial

AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that it has completed the targeted enrollment of 150 subjects in the company’s U.S.-based, multi-center, prospective, randomized, controlled, open-label pivotal study of the AeroForm® patient-controlled tissue expander.

The XPAND study was designed to directly compare outcomes in two-stage breast reconstruction – including successful expansion to implant exchange, average number of days to achieve the desired expansion, total reconstruction time, pain and patient satisfaction with AeroForm versus traditional saline expanders. The traditional method for tissue expansion requires women to visit their physician for frequent injections of saline until they complete the process, which can take up to six months as reported in the literature.

“Today, only around 30-40 percent of women who have had a mastectomy undergo reconstruction, as many women are not aware of their reconstruction options. Some candidates for reconstructive surgery say that the reported long and sometimes painful saline-based expansion process kept them from pursuing that option,” said XPAND Principal Investigator Jeffrey Ascherman, M.D., FACS, site chief of the Division of Plastic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center. “Eliminating some of the office visits required to inflate saline expanders by needle injections is a definite advantage of the new expander over the traditional process. My patients have also appreciated the opportunity to play an active role in recovering their bodies after breast cancer surgery.”

In an interim preliminary review of study data, as reported in the May 2014 edition of the Annals of Plastic Surgery, Kamakshi Zeidler, M.D., FACS at Good Samaritan Hospital in San Jose, California reported that 115 patients were enrolled in the XPAND study and randomized to either the AeroForm or saline group. The group who received the AeroForm patient-controlled expanders completed expansion in an average of 17 days, compared with the saline group whose expansion process extended an average of 52 days (P<0.0001). Dr. Ascherman reported similar results in his publication in the October 2014 issue of the Plastic and Reconstructive Surgery Journal.

At the completion of study enrollment, a total of 98 women were implanted with AeroForm expanders and 52 women with saline expanders. Over 70 percent of women in the trial had bilateral procedures. The women who received AeroForm expanders used a wireless remote control to trigger the release of small, regulated amounts of carbon dioxide to fill the tissue expander, according to a protocol directed by their physician. Once the tissue was adequately expanded, the women returned to have their expanders removed and a standard breast implant placed.

“Completing the enrollment of the primary phase of the XPAND study represents a major milestone for AirXpanders. We are currently focused on following up with the patients, ensuring we have the proper mix of subjects in each group, and completing our 510(k) filing, which we plan to submit to the U.S. Food and Drug Administration very soon. Simultaneously, we have initiated commercial sales of AeroForm in Australia and plan to support a full launch later this year,” said Scott Dodson, president and chief executive officer of AirXpanders. “We are extremely pleased to see consistent results in all of the trials that have been conducted around the world. Preliminary results from the XPAND study indicate positive patient experiences, significantly faster expansion times and decreased time to complete the reconstruction process with the AeroForm expander compared with traditional saline devices. There is every reason to believe that the AeroForm technology will become the new standard of care for all two-stage reconstruction procedures.”

About AirXpanders

AirXpanders Inc. (www.airxpanders.com) is a tissue expansion company focused on the area of breast reconstruction. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of reclaiming one’s body after cancer can potentially be eased with this needle-free technology. This technology is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard of care. At this time, AirXpanders’ products are not cleared or approved for sale. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.

 

Media Contact

Caitlin Nolan

MSLGROUP

AirXpanders@mslgroup.com

415-512-0770

 

Company Contact

Scott Dodson

President & CEO

sdodson@airxpanders.com

650-390-9008

The post AirXpanders Completes Enrollment in XPAND US Pivotal Trial appeared first on Medgadget.

DARPA Sponsors New Self-Administered Pain-Free Blood Testing Tech

Tasso

Blood draws typically require trained professionals to perform and can be both frightening and painful to patients. Tasso, Inc., a spinoff of the Unviersity of Wisconsin-Madison, has developed a device that can be applied by the patients themselves to nearly painlessly draw blood.

The device works thanks to capillary action, slowly pulling in blood through a tiny channel over a two minute period. Once the process is complete, the patient simply takes the device to a clinical lab for testing. Since current methods require refrigeration of blood samples during shipment, DARPA is giving Tasso $3 million to work with other firms to develop a way to extend to a week the time the blood samples can be safely stored at up to 140° F (60° C).

This will allow for all kinds of blood testing away from clinical facilities, as well as easy and convenient way for patients to monitor their conditions without regularly schlepping to the hospital.

Link: Tasso, Inc…

Source: UW-Madison…

The post DARPA Sponsors New Self-Administered Pain-Free Blood Testing Tech appeared first on Medgadget.

SINAIEM 2015-04-17 19:46:09

54 yo F with no PMHx, but admittedly has not been seen by an MD in many years, presents after her daughter visited from our-of-town and found her slightly confused. The patient is disoriented, but able to provide some history. She describes progressive fatigue over several weeks. Vitals signs are remarkable for hypothermia 94F, HR 52, BP 150/90, RR 12, SpO2 100%RA. Exam is notable for AAO2, no focal neuro deficits, prominent facial swelling, and non-pitting lower extremity edema. FS glucose 160. Laboratory analysis is concerning for mild hyponatremia and severe hypothyroidism.

Myxedema

This patient is suffering from myxedema coma. Contrary to its name, myxedema coma does not require your patient be in a comatose state. It refers to AMS in the setting of severe hypothyroidism. Additionally, patients may also be hypothermic, bradycardic, hypotensive, hypoglycemic, and hyponatremic. It is important to rule out more common causes of AMS, while keeping hypothyroid high on the differential in this patient. Checking a fingerstick, as always, should be done at arrival in patient’s with new AMS.

This patient should be admitted and receive IV thyroid replacement. Oral medications may not be fully absorbed secondary to gastrointestinal edema. Finally, myxedema (a dermatologic condition) does not necessarily need to be present in myxedema coma.

Credit: This article is largely based on http://www.nejm.org/doi/full/10.1056/NEJMicm1403210