A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial".

OBJECTIVES: Primary Objective: The primary objective is to reduce initiation of mechanical ventilator dependency in patients with moderate to severe CoViD- 19. This will be measured as the difference between the control group and active group for subjects admitted to the hospital for CoViD-19. Secondary Objectives: • To evaluate cytokine trends / Prevent cytokine storms • To evaluate supplemental oxygen requirements • To decrease mortality of CoViD-19 patients • Delay onset of ventilation TRIAL DESIGN: The study is a single centre, 2-arm, prospective, randomized (ratio 1:1), controlled trial with parallel groups design to compare the reduction of respiratory distress in a CoViD-19 population, using the intervention of the gammaCore®-Sapphire device plus standard of care (active) vs. standard of care alone (SoC) - the control group. The gammaCore® treatments will be used acutely and prophylactically. The active and control groups will be matched for disease and severity. PARTICIPANTS: i. Inclusion Criteria The subjects have to meet all of the following criteria to be eligible to enter the trial: 1.Patient older than 18 years2.Been tested positive or suspected/presumed positive for CoViD-19 Has a cough, shortness of breath or respiratory O2 Saturation less than or equal to 92% without need for mechanical ventilation or acute respiratory failure 3.Agree to use the gammaCore®-Sapphire device as intended and to follow all of the requirements of the study including recording required study data4.Patient is able to provide signed and witnessed Informed Consent ii. Exclusion Criteria Subjects meeting any of the following criteria cannot be included in this research study: 1.Pregnant women2.On home/therapy oxygen (i.e. for patients with Chronic Obstructive Pulmonary Disease) at baseline prior to development of CoViD-193.Patient already enrolled in a clinical trial using immunotherapeutic regimen for CoViD-194.History of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma5.Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction6.Uncontrolled high blood pressure (>140/90)7.Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant8.Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore stimulation site9.Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) Participants will be recruited from Hospital Clínico Universitario de Valencia in Spain. INTERVENTION AND COMPARATOR: Intervention: Prophylactic: Administer 2 doses (at 2 minutes each) of gammaCore®-Sapphire, one dose on each side of the neck scheduled three times a day (morning, mid-day and 1 hour before bed at night).Acute respiratory failure or shortness of breath: Administer 2 doses (at 2 minutes each) of gammaCore®-Sapphire, one on each side of the neck. If shortness of breath (SOB) persists 20 minutes after the start of the first treatment, a second dose will be administered. Max doses per day is 9 or 18 stimulations.Plus standard of care Control: Standard of care: oxygen therapy, antibiotics and ventilatory support if necessary depending on the clinic MAIN OUTCOMES: Primary Endpoint: Initiation of mechanical ventilation, from randomization until ICU admission or hospital discharge, whatever occurs first Secondary Endpoints: Safety; ascertainment of Adverse Effects/Serious Adverse Events, from randomisation to ICU admission or hospital discharge, whatever occurs firstCytokine Storm measured by: Tumor necrosis factor α, Interleukin 6, Interleukin 1ß. Days 1,3,5,10,15 and/or at hospital dischargeMortality and/or need for Critical Care admission, from randomisation until ICU admission or hospital discharge, whatever occurs first,O2 saturation levels , from randomization until ICU admission or hospital discharge, whatever occurs firstNeed for supplemental oxygen, from randomisation until ICU admission or hospital discharge, whatever occurs first RANDOMISATION: The patients are classified according to their oxygen levels as mild, moderate and severe and randomized according to their classification to the intervention and control in a ratio of 1:1. The randomization will be stratified for gender and age. BLINDING (MASKING): This is an open label study, it is not possible to blind the participants and healthcare providers to the intervention. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total number of patients to be included in the study is 90, with 45 in each study group TRIAL STATUS: The protocol version is 8.0 from 07th April 2020. The recruitment began 20th April 2020 and is expected to be complete 31st July 2020. TRIAL REGISTRATION: The study is registered in clinicaltrials.gov on 29th April 2020 with the identification number: NCT04368156 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial.

BACKGROUND: Tracheal intubation failure in patients with difficult airway is still not uncommon. While videolaryngoscopes such as the Glidescope offer better glottic vision due to an acute-angled blade, this advantage does not always lead to an increased success rate because successful insertion of the tube through the vocal cords may be the limiting factor. We hypothesize that combined use of Glidescope and fiberscope used only as a dynamic guide facilitates tracheal intubation compared to a conventional Glidescope technique with a preshaped nondynamic stylet. METHODS: One hundred sixty adult patients with predicted difficult airway were randomly assigned to a conventional Glidescope (standard Glidescope group) or a combined Glidescope + fiberscope group intubation. In the Glidescope + fiberscope group under direct vision from the Glidescope, tracheal intubation was performed using the fiberscope as a guide without using fiberoptic vision, while in the standard Glidescope group, a conventional stylet-guided intubation technique was performed. We evaluated the rate of tracheal intubation success at first attempt as the primary end point (Fisher exact test). The difference between groups in airway injury, time to successful intubation, and the need for an alternative technique was also evaluated. RESULTS: First-attempt intubation success was higher in the Glidescope + fiberscope group than in the standard Glidescope group (91% vs 67%; P = .0012; fragility index, 8; absolute risk reduction, 24% [95% CI, 12%-36%]). Median time to successful tracheal intubation was shorter in the Glidescope + fiberscope group (50 vs 64 seconds; P = .035). Airway injury rate was lower in the Glidescope + fiberscope group than in the standard Glidescope group (1% vs 11%; P = .035; fragility index, 1; absolute risk reduction, 10% [95% CI, 3%-18%]). Alternative rescue technique requirements to achieve tracheal intubation were higher in the standard Glidescope group (24% vs 4%; P < .001; fragility index, 7). CONCLUSIONS: The use of a dynamic, flexible guide during a Glidescope laryngoscopy in patients with a predicted difficult airway compared to a standard intubation technique improves first-attempt intubation success, decreases the incidence of airway injury and time to successful intubation, as well as the need of an alternative technique to succeed.

Interfascial block at the serratus muscle plane versus conventional analgesia in breast surgery: a randomized controlled trial.

BACKGROUND AND OBJECTIVES: In the context of opioid-sparing perioperative management, there is still little evidence from randomized controlled trials regarding the effectiveness of interfascial thoracic blocks. This study hypothesizes that receiving a serratus plane block reduces opioid requirements, pain scores, and rescue medication needs. METHODS: This double-blind, randomized controlled study was conducted on 60 adult females undergoing oncologic breast surgery. After general anesthesia, patients were randomly allocated to either conventional analgesia (control group, n=30) or single-injection serratus block with L-bupivacaine 0.25% 30mL (study group, n=30). First 24-hour total morphine consumption (primary outcome), pain scores at 1, 3, 6, 12, and 24 hours, time-to-first opioid rescue analgesia, and adverse effects were recorded. RESULTS: Median 24 hours' opioid dose was greater in the control group (median difference 9 mg (95% CI 4 to 14.5 mg); p<0.001). Proportional odds model showed that the study group has a lower probability of receiving opioid drugs (OR=0.26 (95% CI 0.10 to 0.68); p<0.001), while mastectomies have a higher probability of receiving them (OR=4.11 (95% CI 1.25 to 13.58); p=0.002). Pain scores in the study group were significantly lower throughout the follow-up period (p<0.001). Control group subjects needed earlier morphine rescue and had a higher risk of rescue dose requirement (p=0.002). CONCLUSIONS: Interfascial serratus plane block reduces opioid requirements and is associated with better pain scores and lower and later rescue analgesia needs in the first 24 hours, compared with conventional intravenous analgesia, in breast surgery. TRIAL REGISTRATION NUMBER: NCT02905149.