Clinical Voices May 2023

May 04, 2023

Added to Collection

In this issue, read about FDA guidance to prevent device misconnections, video/phone consults in pediatric emergencies, predicting delirium with machine learning, and more. Plus, read a new nurse story on acuity-based staffing.

FDA Guidance for Preventing Device Misconnections

Device connectors whose designs meet voluntary consensus standards reduce the risk of misconnections.

The U.S. Food and Drug Administration (FDA) is providing guidance on consensus standards for medical device connections, including visual depictions of misconnections and tips to reduce errors and evaluate the potential for harm.

Referencing case studies reported to the FDA, the guidance in “Examples of Medical Device Misconnections,” on, designates the severity of possible patient harm in each case as high, medium or low and provides images of erroneous connections. “This page offers patients and health care providers safety tips and recommendations to reduce device misconnections,” the article adds.

The article notes that device connectors whose designs meet the FDA’s voluntary consensus standards reduce the risk of misconnections. The agency also notes that the likelihood of errors should decrease as new designs for high-risk delivery systems enter mass circulation and organizations develop standards for other types of connectors.

The article adds that misconnections can occur when connectors do not conform to standards or do not yet have an applicable standard. Clinicians can learn more about the following topics, which are covered in detail:

  • Epidural tubing erroneously connected to IV tubing
  • IV tubing erroneously connected to trach cuff
  • IV tubing erroneously connected to nebulizer
  • IV tubing erroneously connected to nasal cannula
  • IV tubing erroneously connected to enteral feeding tube
  • Oxygen tubing erroneously connected to needleless IV port
  • Blood pressure tubing erroneously connected to IV catheter
  • Syringe erroneously connected to trach cuff
  • Air-filled syringe for limb tourniquet cuff erroneously connected to introducer sheath
  • Enteral feeding tube erroneously connected to ventilator in-line suction catheter
  • Air inflation line from noninvasive vascular diagnostic system erroneously connected to IV catheter
  • Pulsatile anti-embolism stocking erroneously connected to IV heparin lock
  • Foley catheter erroneously connected to NG tube
  • Incorrect dialysate canister mix-up during hemodialysis therapy

New Guideline for Temporary Circulatory Support

Recommendations cover types of shock along with timing and requirements for using MCS.

A new guideline for acute mechanical circulatory support (MCS) for patients in cardiogenic or pulmonary shock provides recommendations and protocols for surgical interventions, patient and device selection, ethical dilemmas, supportive care and related factors.

The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support,” in Journal of Cardiac Failure, is a collaborative effort to help clinicians improve patient outcomes by providing temporary organ support.

The recommendations cover types of shock along with the timing and requirements for use of MCS. Roles are described for circulatory support teams, intensivists, nurses and others treating patients supported by temporary devices.

“The most important aspect of team-based care of the CS [cardiogenic shock] patient is the relational coordination of the multidisciplinary team, not the management of materials or resources,” the guideline notes.

Key topics include pharmacologic management of bleeding, thrombosis and infection, as well as specific patient populations, such as women, minorities, the elderly and patients with congenital heart disease. The importance of informed patient consent, palliative care, social work and ethics is also covered.

“Decision-making for acute MCS is typically rapid and complex, and involves a variety of invasive options, a high degree of uncertainty in outcomes, and the potential for significant patient and family suffering,” the guideline adds.

A related article in Cardiovascular Business notes that devices in the guideline include intra-aortic balloon pumps, Impella heart pumps, extracorporeal life support and extracorporeal membrane oxygenation devices, CentriMag systems and centrifugal pumps.

“While reviews and consensus statements have been published on similar topics, this is the first guideline to provide evidence-based recommendations for the use of acute MCS and should serve as a critical roadmap to optimize care and improve outcomes of our sickest patients,” lead author Michael Givertz, Harvard Medical School and Brigham and Women’s Hospital in Boston, adds in the related article.

Video or Telephone Consults in Pediatric Emergencies?

Telemedicine can support ED clinicians’ ability to care for pediatric patients locally.

For acutely ill children in rural communities, telemedicine consultations can improve decision-making and help prevent unnecessary transfers to regional pediatric centers.

Impact of Tele-Emergency Consultations on Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial,” in JAMA Network Open, finds that compared with telephone consultations, significantly fewer pediatric transfers occur when emergency departments (EDs) connect with families via audiovisual communication.

“Using telemedicine with a remote pediatric specialist provides local physicians and families with more support, both clinically and emotionally, than a standard telephone conversation and could result in lower levels of parental distress,” the study suggests. “In addition, telemedicine can be used to include the referring bedside nurse, which could increase their confidence in caring for children in their own EDs.”

The study involved 696 acutely ill children (mean age 4.2 years) presenting to 15 rural and community EDs in Northern California from November 2015 to March 2018. Of those, 251 patients (36.1%) received telemedicine assessments, while 445 (63.9%) had telephone consultations. Transfers to UC Davis Children’s Hospital in Sacramento, California, comprised 84% of telemedicine patients compared with 90.6% in the telephone group.

Telemedicine routinely involved the referring ED physician, bedside nurse and respiratory therapist, and the sessions always included direct physical assessment of the patient. Measurements to determine transfer risk included intention-to-treat, treatment received and per-protocol analyses.

“We found that by using a relatively low-cost telemedicine intervention, children can be successfully evaluated, treated and either discharged or admitted locally from their rural and community hospitals,” lead study author James Marcin, UC Davis Health, says in a related article in mHealth Intelligence. “Our findings are important because they demonstrate that telemedicine can support emergency department clinicians’ ability to care for pediatric patients locally.”

Machine Learning Effective for Predicting Delirium

Predictive models represent a shift toward preventive and personalized medicine.

Machine learning models proved highly effective at predicting the onset of delirium in ICU patients up to 12 hours in advance, with accuracy rates up to 90%.

In “Predicting Intensive Care Delirium With Machine Learning: Model Development and External Validation,” in Anesthesiology, two types of predictive models used patient information from a multicenter database with a development sample and two validation samples to test for delirium. “After further prospective testing and validation, these models could help support the implementation of delirium-reducing interventions in high-risk individuals,” the study notes.

The 24-hour model used data the first 24 hours after a patient’s ICU admission and was asked to predict the onset of delirium at any time after. This model identified delirium in 11.9% to 14.5% of patient stays. In addition, the 24-hour model outperformed the modified reference mode mean (0.730) under the receiving operating characteristic curve (AUC) with a value of 0.785.

The dynamic model aimed to predict the onset of delirium up to 12 hours in advance using data throughout an ICU stay. This model identified delirium in 16.1% to 20.9% of cases, producing a mean AUC of 0.845 with a maximum of 0.859 at the shortest lead time.

Senior study author Robert Stevens, The Johns Hopkins University School of Medicine, interviewed in a related article in Healio News, says that “predictive models are the basis for a paradigm shift toward preventive and personalized medicine. With validation, clinicians will be able to leverage model outputs to mitigate risk for delirium through targeted interventions.”

The study envisions eventual implementation of systems that “could be leveraged for anti-delirium interventions.” Stevens notes in the interview that future studies “will use AI to unpack the complexity or heterogeneity of delirium which encompasses many different sub-phenotypes, each with specific biological mechanisms and treatment responses.”

Training Together: Nursing and Medical Students Gain Insight

Students gained perspective on each other’s expertise and the importance of explicit and responsive communication.

Nursing and medical students who train together in simulated acute care situations show measurable growth in interprofessional collaboration and communication, but so do students who train with other students from the same profession.

Interprofessional Simulation of Acute Care for Nursing and Medical Students: Interprofessional Competencies and Transfer to the Workplace,” in BMC Medical Education, also suggests that students from the same profession who train together become more aware of the other profession’s role, in addition to their own.

Nursing students said “they gained growing insight in their role in acute situations; they became more proud of their own profession,” the study notes. “Medical students realized the added value of a nurse in acute situations, and both groups said they improved their communicative skills during the interprofessional training.”

In the study, 191 students (131 medical, 60 nursing) in the Netherlands were randomly assigned to small groups for either interprofessional or uniprofessional acute care training. Simulated scenarios included a deteriorating patient in a hospital setting.

Using a pair of surveys, the study collected quantitative data on communication, collaboration, conflict management, responsibilities and other factors before and after training. No significant differences in overall scores were recorded between the two groups, the study notes.

However, comments from students receiving interprofessional training indicate they were happy to gain perspective on each other’s expertise as well as the importance of explicit and responsive communication.

Medical students said they became more appreciative of nurses’ perspectives. One of them notes, “We were encouraged to think out loud so the nurse could follow our thoughts and we knew what the nurse was thinking. That makes collaboration easier,” the study adds.

Spirituality and Its Association With Moral Distress

A review looked at the association between spirituality, moral distress and resilience.

A review of studies on moral distress in critical care staff finds that spirituality can create challenges due to ethical concerns, and coping tools may not improve resilience.

Influence of Spirituality on Moral Distress and Resilience in Critical Care Staff: A Scoping Review,” in Intensive and Critical Care Nursing, notes that “spirituality does not automatically help the critical care staff to cope with moral distress and strengthen resilience. Institutions need to create conditions in which the critical care staff are supported to use their spiritual resources.”

The review included 13 in-depth qualitative and quantitative studies with over 4,000 subjects in five countries. More than half the critical care nurses indicated spirituality was part of their moral distress when faced with suffering and tragedy. Younger nurses participated more often and in more programs offered by institutions to build resilience.

The review indicates that spirituality alone could lead to ambivalent outcomes during potentially difficult situations and when needing to boost resilience. An ethical challenge can lead to moral distress, and some staff described feeling abandoned or punished by God. “The higher risk of suffering from moral distress due to spirituality is explained by the fact that spiritual critical care staff might perceive higher moral standards than less spiritual critical care staff from which they do not want to diverge on the job,” the review notes.

Critical care staff employed spirituality as a coping strategy, using faith and hope, reflection and counseling as tools, but they expressed the need for support on the last two. “They preferred to have a guided conversation with a person who is not part of the team and who has emotional and spiritual skills; for example social workers, chaplains, or spiritual care providers,” the review adds.

Nurse Story: Acuity-based Staffing

At LAC+USC Medical Center in Los Angeles, an acuity-based staffing approach led to real-time assignments that efficiently delegated care to patients. Direct care nurses say the “smart assignments” resulted in evenly distributed work that reduced burnout and created new opportunities.

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