Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid. Final order.

The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Management of Patients with Predicted Difficult Airways in an Academic Emergency Department.

BACKGROUND: Patients with difficult airways are sometimes encountered in the emergency department (ED), however, there is a little data available regarding their management. OBJECTIVES: To determine the incidence, management, and outcomes of patients with predicted difficult airways in the ED. METHODS: Over the 1-year period from July 1, 2015 to June 30, 2016, data were prospectively collected on all patients intubated in an academic ED. After each intubation, the operator completed an airway management data form. Operators performed a pre-intubation difficult airway assessment and classified patients into routine, challenging, or difficult airways. All non-arrest patients were included in the study. RESULTS: There were 456 patients that met inclusion criteria. Fifty (11%) had predicted difficult airways. In these 50 patients, neuromuscular blocking agents (NMBAs) were used in 40 (80%), an awake intubation technique with light sedation was used in 7 (14%), and no medications were used in 3 (6%). In the 40 difficult airway patients who underwent NMBA facilitated intubation, a video laryngoscope (GlideScope 21, Verathon, Bothell, WA and C-MAC 19, Karl Storz, Tuttlingen, Germany) was used in each of these, with a first-pass success of 90%. In the 7 patients who underwent awake intubation, a video laryngoscope was used in 5, and a flexible fiberoptic scope was used in 2. Ketamine was used in 6 of the awake intubations. None of these difficult airway patients required rescue with a surgical airway. CONCLUSIONS: Difficult airways were predicted in 11% of non-arrest patients requiring intubation in the ED, the majority of which were managed using an NMBA and a video laryngoscope with a high first-pass success.

Determining the Efficiency of Different Preoperative Difficult Intubation Tests on Patients Undergoing Caesarean Section.

BACKGROUND: Pregnancy-induced anatomical and physiological changes in the airway make airway management difficult in obstetric patients; thus, preoperative evaluation of the airway is important for obstetric patients. AIMS: To determine the effectiveness of the modified Mallampati test; the interincisor, sternomental and thyromental distances and the upper limb bite test. The second aim was to assess the effectiveness of the combination of the upper limb bite test with the other tests in obstetric patients. STUDY DESIGN: Cross-sectional study. METHODS: Pregnant women (n=250) scheduled for caesarean section were analysed. The patients' ages, heights and weights were collected. Preoperative airway evaluation was done by using a modified version of the Mallampati test. The interincisor, sternomental and thyromental distances were measured, and the upper limb bite test was performed. The laryngoscopy difficulty was evaluated by using Cormack-Lehane classification. RESULTS: No statistically significant differences were found between groups in age, height or weight (p>0.05). The modified Mallampati test and interincisor, sternomental and thyromental distances revealed a lower number of easy intubations than that determined by the Cormack-Lehane classification and a higher number of difficult intubations than the actual number of cases (p<0.05). The sensitivity and specificity of the modified Mallampati test, the upper limb bite test, the interincisor distance test and the sternomental and thyromental distance tests were found to be 73.08, 57.69, 84.62, 80.77 and 88.46 and 90.62, 99.11, 83.04, 84.37 and 87.05, respectively. When the combinations were examined, the sensitivity and specificity of the combination of the upper limb bite test with the modified Mallampati test were found to be 57.69 and 100, respectively. When the upper limb bite test was combined with the interincisor distance, the sensitivity and specificity were 46.15 and 100, respectively. We found a sensitivity and specificity of 93.75 and 95.30, respectively, for the combination of the upper limb bite test with the thyromental distance test. The sensitivity and specificity of the combination of the upper limb bite test with the modified Mallampati test and interincisor distance test were found to be 46.15 and 100, respectively. For combination of all the tests, the sensitivity and specificity was 42.31 and 100, respectively. CONCLUSION: When all combinations are evaluated in the decision of difficult intubation, the combination of the upper limb bite test and thyromental distance test is superior to the use of other methods alone to predict difficult intubation in pregnant women.

A child with a difficult airway: what do I do next?

PURPOSE OF REVIEW: Difficulties in pediatric airway management are common and continue to result in significant morbidity and mortality. This review reports on current concepts in approaching a child with a difficult airway. RECENT FINDINGS: Routine airway management in healthy children with normal airways is simple in experienced hands. Mask ventilation (oxygenation) is always possible and tracheal intubation normally simple. However, transient hypoxia is common in these children usually due to unexpected anatomical and functional airway problems or failure to ventilate during rapid sequence induction. Anatomical airway problems (upper airway collapse and adenoid hypertrophy) and functional airway problems (laryngospasm, bronchospasm, insufficient depth of anesthesia and muscle rigidity, gastric hyperinflation, and alveolar collapse) require urgent recognition and treatment algorithms due to insufficient oxygen reserves. Early muscle paralysis and epinephrine administration aids resolution of these functional airway obstructions. Children with an 'impaired' normal (foreign body, allergy, and inflammation) or an expected difficult (scars, tumors, and congenital) airway require careful planning and expertise. Training in the recognition and management of these different situations as well as a suitably equipped anesthesia workstation and trained personnel are essential. SUMMARY: The healthy child with an unexpected airway problem requires clear strategies. The 'impaired' normal pediatric airway may be handled by anesthetists experienced with children, whereas the expected difficult pediatric airway requires dedicated pediatric anesthesia specialist care and should only be managed in specialized centers.

Traumatic airway management in Operation Iraqi Freedom.

OBJECTIVES: To examine the role of head and neck surgeons in traumatic airway management in Operation Iraqi Freedom and to understand the lessons learned in traumatic airway management to include a simple airway triage classification that will guide surgical management. STUDY DESIGN: Case series with chart review. SETTING: Air Force Theater Hospital at Balad Air Base, Iraq. SUBJECTS AND METHODS: The traumatic airway experience of 6 otolaryngologists/head and neck surgeons deployed over a 30-month period in Iraq was retrospectively reviewed. RESULTS: One hundred and ninety-six patients presented with airway compromise necessitating either intubation or placement of a surgical airway over the 30-month timeframe. Penetrating face trauma (46%) and penetrating neck trauma (31%) were the most common mechanisms of injury necessitating airway control. The traumatic airways performed include 183 tracheotomies, 3 cricothyroidotomies, 9 complicated intubations, and 1 stoma placement. Red or emergent airways were performed in 10% of patients, yellow or delayed airways in 58% of patients, and green or elective airways in 32% of patients. Lastly, surgical repair of the laryngotracheal complex was performed in 25 patients with 16 thyroid cartilage repairs, 4 cricoid repairs, and 8 tracheal repairs. CONCLUSIONS: The role of the deployed otolaryngologist in traumatic airway management was crucial. Potentially lifesaving airways (red/yellow airways) were placed in 68% of the patients. The authors' recommended treatment classification should optimize future traumatic airway management by stratifying traumatic airways into red (airway less than 5 minutes), yellow (airway less than 12 hours), or green categories (airway greater than 12 hours).