By Laura Hale Brockway, ELS, Assistant Vice President, Marketing, and
Kassie Toerner, Senior Risk Management Representative
A 58-year-old woman came to an orthopedic surgeon reporting unrelenting back pain and radiculopathy into her right leg. The patient described the pain as 10 out of 10. She had tried physical therapy and chiropractic therapy for her back pain without relief.
The patient’s history included morbid obesity (she was 5’4” and weighed 203 pounds), hypertension, coronary artery disease, rheumatoid arthritis, anemia, and sleep apnea.
The orthopedic surgeon ordered several studies that revealed stenosis and foraminal stenosis with severe central stenosis at L2-3 and L3-4. Studies also showed autofusion at L1-2 and possibly at L4-5.
The orthopedic surgeon recommended anterior lumbar interbody fusion at L5-S1 with osteotomies at L2 and L3 with cage reconstruction at L2-3 and L3-4 and probable fusion at L4-5. The patient would also require laminectomies and foraminotomies at L2 and L5 with instrumented posterior spinal fusion at T9 or T10 to the pelvis.
The patient consented to the procedures, and medical clearance was given by her primary care physician on June 16. Cardiovascular clearance (including an assessment and echocardiogram) was given by the patient’s cardiologist on May 10.
On June 29, the patient was admitted to a local hospital for a two-stage spinal fusion surgery. Medications on admission included modafinil, ramipril, levothyroxine, zolpidem, etanercept, hydrocodone/acetaminophen, and nitroglycerine.
Anesthesiologist A provided anesthesia for both stages of the surgery. The first stage of surgery was uneventful. The patient remained in the ICU until the second stage two days later.
At 6:35 a.m. on July 1, Anesthesiologist A saw the patient for a pre-anesthesia visit. At 7:15, the patient was transferred to the OR and general anesthesia was used for induction. Anesthesiologist A placed a right internal jugular central venous catheter. A chest x-ray confirmed placement of the central line. A right radial arterial line was also placed before the procedure began.
The procedure began uneventfully at 7:57 a.m. Anesthesiologist A induced hypotension to minimize intraoperative blood loss, using small boluses of ephedrine to support a systolic blood pressure of above 80 mm Hg. The infusion of blood products continued through the central line and multiple venous samples were obtained without difficulty.
As the case progressed, the patient’s hemoglobin remained the same despite multiple units of packed red blood cells (PRBCs). The patient was also requiring greater doses of pressor agents and the use of ephedrine and phenylephrine to maintain her blood pressure.
At 12:30 p.m., the patient then lost the integrity of the somatosensory evoked potentials (SSEPs) in her right and left arm. Anesthesiologist A asked the orthopedic surgeon to stop the procedure and begin closing. The orthopedic surgeon agreed, but the patient sustained a small dural tear that had to be repaired followed by the closure of the wound. This process took 45 minutes.
During this time, Anesthesiologist A used norepinephrine for blood pressure support. He also called in another anesthesiologist and a vascular surgeon to assist.
At 1:15 p.m., the patient was moved to the prone position. Her right side, including her neck, shoulder, and upper arm were swollen from infiltration of the CVP line. With help from Anesthesiologist B, a new left brachial line was placed and blood work was sent to the lab. The initial systolic blood pressure was over 100 mm Hg. A double-lumen catheter was placed in the left femoral vein and transfusion initiated. The patient’s HCT was around 14-15%.
Three units of PRBCs were transfused quickly and the patient’s next HCT was 28.7. The swelling had subsided, and the left and right chest seemed to be the same based on palpation. The patient was admitted to the ICU.
Postoperatively, the patient remained intubated and ventilated in critical condition. A CT scan showed anoxic brain injury, and care was withdrawn. The patient died on July 2.
A lawsuit was filed against Anesthesiologist A. The allegations included:
- failure to assess the patency of the central line;
- failure to tell the surgeon to stop the procedure due to blood loss and hypotension; and
- failure to obtain additional adequate and patent intra-vascular access before placing the patient in the prone position
Defense consultants who reviewed this case were supportive of Anesthesiologist A. He confirmed placement of the central line by aspirating blood, transducing the central venous pressure, and obtaining a chest x-ray. The chest x-ray reported the catheter over the internal jugular vein and the brachiocephalic vein.
When the intraoperative complications occurred, Anesthesiologist A treated those immediately and aggressively. The outcome was unforeseeable.
In his deposition, Anesthesiologist A stated that he believed the central line became dislodged at 12:45 p.m. when he attempted to manipulate the patient’s neck to obtain better SSEP signals. He asked for the case to be stopped, but there was a delay because the orthopedic surgeon had to repair a dural tear, place the bone back in the gutters, and close a 15-to-18-inch incision.
The plaintiff’s expert argued that Anesthesiologist A should have insisted the procedure be stopped immediately, even if it meant not closing. This expert testified that had the patient been flipped within 30 minutes of the loss of the SSEPs, he believes they could have saved her. Another expert for the plaintiff was critical because the central line was in an “adequate but not ideal position.”
This case was settled on behalf of Anesthesiologist A.
Risk management considerations
Managing and monitoring higher risk patients during surgical procedures can create challenges and, at times, unanticipated outcomes. The National Patient Safety Foundation (NPSF) at the American Medical Association (AMA) has four core strategies for enhancing patient safety and preventing surgical errors. They include promoting research on safety and human and organizational errors; implementing that research and developing methods to prevent avoidable risk; and developing educational and collaborative relationships with other organizations to further research patient safety. 1
One additional strategy is “fostering communication to enhance patient safety.” The NPSF feels that “early identification of risk is the key to preventing patient injuries, and this depends on maintaining a culture of trust, honesty, integrity, and open communication among patients and providers in the health care system.” 1
All communications, such as conversations with other physicians or members of the health care team, that affect a medical decision should be documented in the patient’s medical chart. The American College of Obstetricians and Gynecologists suggests that “communication among members of the surgical team is crucial throughout the surgical process, particularly during the preoperative phase.” 2
It is also recommended that all diagnostic and laboratory results be reviewed and signed electronically or manually to verify that results have been seen in a timely manner.
Anesthesiologist A documented review of the chest x-ray and laboratory results. It is crucial that discussions with consultants regarding diagnostic and laboratory results be documented in the patient’s medical chart. Additionally, preoperative and intraoperative medication should be documented with the time, route and dosage, and any adverse reaction.
It is also vital that all surgical patients or person(s) authorized to consent for a patient have been informed of the possible risks and benefits of the recommended procedure. For scheduled and elective procedures, the patient should be provided adequate time to consider the risks and make an informed decision to proceed with the recommended procedure.
Discussion of the risks and benefits and obtaining and documenting informed consent during an office visit before a procedure is prudent. Additionally, documentation of informed consent discussions between the patient and physicians on the day of the procedure is critical.
Informed consent of the possible risks and hazards involved in anesthesia should also be discussed with the patient by the anesthesiologist before the procedure and documented in the patient’s medical record. Informed consent, documentation, and communication and collaboration with other members of the health care team is paramount in reducing unforeseeable outcomes.
https://jamanetwork.com/journals/jama/article-abstract/188093. Accessed March 31, 2020.
2.American College of Obstetricians and Gynecologists Committee on Patient Safety and Quality Improvement. Committee Opinion: Patient safety in the surgical environment. Number 464 (Replaces No. 328, February 2006. Reaffirmed 2014). Available at https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2010/09/patient-safety-in-the-surgical-environment. Accessed March 31, 2020.