Auriculotherapy in prevention of migraine attacks: an open randomized trial.

Use of auriculotherapy to prevent episodic migraine pain has seldom been reported. The aim of this open study was to show that three sessions of auriculotherapy, 1 month apart, using semi-permanent needles decrease frequency and intensity of an attack in patients presenting episodic migraine. A total of 90 patients were randomized to the treatment group (AUR group, n = 58) or the control group (C group, n = 32). Four patients dropped out during the study (three in the AUR group and one in the C group). The number of days with migraine and non-migraine headache was similar when the analysis focused on the 3 months of the study or on the difference in each group of this number between the 3 months preceding the inclusion and the 3 months of the study (p = 0.123). AUR group patients had fewer days with non-migraine headache (p = 0.011) and took less Triptans (p = 0.045) than group C. Number of days with migraine, sum of the pain intensities of all migraines and non-migraine headaches, and total number of analgesics taken, other than triptan, were similar between groups. MIDAS score decreased with time in the AUR group while it increased in the C group whether in absolute values (p = 0.035) or as categories (p = 0.037). These contrasted results should lead to further study of the effectiveness of auriculotherapy for the prevention of migraine. Clinical trail registration: Protocol registered on the Clinicaltrials.gov, website (January 30, 2017, NCT03036761).

Ultrasound assessment of the gastric content among diabetic and non-diabetic patients before elective surgery: a prospective multicenter study.

BACKGROUND: Although diabetic gastroparesis could be responsible for delayed gastric emptying, there is conflicting evidence about the volume of gastric content in diabetic patients after preoperative fasting. We hypothesized that diabetic patients had an increased gastric content before anesthesia induction despite the following of fasting recommendations. We used ultrasound assessment of gastric content to evaluate this risk. METHODS: This multicenter prospective single-blinded case-control study was conducted in three teaching University hospital in France. Our primary outcome was the comparison of increased gastric content between the two groups and was defined either by a Perlas grade 2 antrum or an antral cross-sectional area (CSA)>340 mm2. Each diabetic patient was paired with three non-diabetic control patients. Forty-two diabetic and 126 control patients were included in the study. RESULTS: Eighteen (42.9%) diabetic patients reached the primary outcome versus 28 (22.2%) in the control group (P=0.009). Diabetic patients presented less frequently with an empty stomach. Indeed, ten (23.8%) diabetic patients had a grade 0 antrum versus 71 (56.3%) in the control group (P<0.001). Twenty-four (70.6%) diabetic patients had an antral CSA<340 mm2 versus 98 (86%) in the control group (P=0.039). Overall, diabetic patients and increased gastric content were associated with an Odds Ratio, 2.63; 95% confidence interval, 1.25-5.52, P=0.009. CONCLUSIONS: Our study documents that gastric content is increased among diabetic patients compared to control patients despite following appropriate fasting guidelines.

Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial.

OBJECTIVE: We hypothesised that videolaryngoscopy modifies practice of tracheal intubation. DESIGN: Randomised single-blinded study (video and no-video groups). SETTING: Three institutions: one academic, one non-profit and one profit. PARTICIPANTS: Patients >18 years, requiring orotracheal intubation, without predicted difficult intubation. Non-inclusion criterion was patients requiring a rapid-sequence intubation. 300 patients were included, 271 randomised, 256 analysed: 123 in the no-video and 133 in the video groups. INTERVENTION: Tracheal intubation using a McGrath Mac videolaryngoscope, the sequence being video recorded. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the proportion of intubations where assistance is necessary on request of the operator. Secondary outcomes included intraoperative variables (intubation difficulty scale and its components, percentage of glottic opening score, oesophageal Intubation, duration of intubation, removal of the screen cover in the no-video group, global evaluation of the ease of intubation, bispectral index, heart rate and blood pressure), intraoperative and postoperative complications (hoarseness or sore throat) and cooperation of the anaesthesiology team. RESULTS: Requirement for assistance was not decreased in the Video group: 36.1% (95% CI 27.9 to 44.9) vs 45.5% (95% CI 36.5 to 54.7) in the no-video group, p=0.74; OR: 0.7 (95% CI 0.4 to 1.1) and absolute risk: 0.10 (95% CI -0.03 to 0.22). Intubation difficulty scale was similar in both groups (p=0.05). Percentage of glottic opening score was better in the Video group (median of 100 (95% CI (100 to 100) and 80 (95%CI (80 to 90) in the no-video group; p<0.001) as Cormack and Lehane grade (p=0001). Ease of intubation was considered better in the video group (p<0.001). Other secondary outcomes were similar between groups. Screen cover was removed in 7.3% (95% CI (2.7 to 11.9)) of the cases in the video group. No serious adverse event occurred. Communication and behaviour within the anaesthesia team were appropriate in all cases. CONCLUSION: In patients without predicted difficult intubation, videolaryngoscopy did not decrease the requirement for assistance to perform intubation. TRIAL REGISTRATION NUMBER: NCT02926144; Results.

Screening for postoperative vital signs abnormalities, and particularly hemodynamic ones, by continuous monitoring: protocol for the Biobeat-Postop cohort study.

Background: Postoperative hypotension associated with postoperative morbidity and early mortality has been studied previously. Hypertension and other hemodynamic, respiratory, and temperature abnormalities have comparatively understudied during the first postoperative days. Methods: This bi-centre observational cohort study will include 114 adult patients undergoing non-cardiac surgery hospitalized on an unmonitored general care floor and wearing a multi-signal wearable sensor, allowing remote monitoring ( Biobeat Technologies Ltd, Petah Tikva, Israel). The study will cover the first 72 hours after discharge of the patient from the post-anaesthesia care unit. Several thresholds will be used for each variable (arterial pressure, heart rate, respiratory rate, oxygen saturation, and skin temperature). Data obtained using the sensor will be compared to data obtained during the routine nurse follow-up. The primary outcome is hemodynamic abnormality. The secondary outcomes are postoperative respiratory and temperature abnormalities, artefacts and blank/null outputs from the wearable device, postoperative complications, and finally, the ease of use of the device. We hypothesize that remote monitoring will detect abnormalities in vital signs more often or more quickly than the detection by nurses' routine surveillance. Discussion: A demonstration of the ability of wireless sensors to outperform standard monitoring techniques paves the way for the creation of a loop which includes this monitoring mode, the automated creation of alerts, and the sending of these alerts to caregivers. Trial registration: ClinicalTrials.gov, NCT04585178. Registered on October 14, 2020.

Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit.

INTRODUCTION: Except for operating rooms, postanaesthesia care units and intensive care units, where the monitoring of vital signs is continuous, intermittent care is standard practice. However, at a time when only the patients with the most serious conditions are hospitalised and only a fraction of these patients are in intensive care units, this type of monitoring is no longer sufficient. Wireless monitoring has been proposed, but it requires rigorous validation. The aim of this observational study is to compare vital signs obtained from a precordial patch sensor to those obtained with conventional monitoring. METHODS AND ANALYSIS: This patch validation trial will be an observational, prospective, single-centre open study of 115 anaesthetised adult patients monitored with both a wireless sensor (myAngel VitalSigns, Devinnova, Montpellier, France) and a standard bedside monitor (Carescape Monitor B850, GE Healthcare, Chicago, Illinois). Both sensors will be used to record peripheral oxygen saturation, respiratory rate, heart rate, body temperature and blood pressure (systolic and diastolic). The main objective will be to assess the degree of agreement between the two systems during the patients' stay in the postanaesthesia care unit, both at the raw signal level and at the clinical parameter level. The secondary objectives will be to assess the same performance under anaesthesia, the frequency of missing data or artefacts, the diagnostic performance of the systems, the influence of patients' characteristics on agreement between the two systems, the adverse events and the acceptability of the patch to patients. Bland-Altman plots will be used in the main analysis to detect discrepancies and estimate the limits of agreement. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethical Committee (Toulouse, France) on 10 April 2020. We are not yet recruiting subjects for this study. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04344093.

Hands-free induction of general anesthesia: a randomised pilot study comparing usual care and high-flow nasal oxygen.

BACKGROUND: The induction of general anesthesia is preceded by face mask preoxygenation and oxygen delivery during intubation (peroxygenation). High-flow nasal oxygen (HFNO) may be an effective alternative. METHODS: In this multicenter randomized controlled study, adults undergoing general anesthesia with oral intubation were included, provided written consent, and were assigned to the control group (face mask) or experimental group (HFNO). The primary objective was to validate HFNO as a safe and efficient technique for preoxygenation and peroxygenation. The main outcome was the risk of oxygen desaturation (SpO2≤92%). Analysis was performed with the intention-to-treat principle. RESULTS: Among 68 eligible patients, 61 completed the study (31 in the face mask group and 30 in the HFNO group). The patient characteristics were comparable between groups. A decrease in SpO2 was observed in the HFNO group (P=0.491). Oesophageal intubation at the first attempt occurred twice in the HFNO group, with no oxygen desaturation, and never occurred in the face mask group (P=0.238). There was no difference in airway management or hemodynamic recordings between the groups. The end-tidal CO2 levels at intubation were similar between the groups: 5.1 (4.7-5.7) kPa in the face mask group vs. 5.2 (4.8-6.0) kPa in the HFNO group (P=0.292). HFNO was preferred by the investigators (P=0.003) and patients, with improved comfort (P=0.018), less submandibular pain (P=0.003), and a similar severity of hoarseness (P=0.686). CONCLUSIONS: HFNO provides a hands-free induction of general anesthesia and yields adequate preoxygenation and peroxygenation, with a significant improvement in the quality of care.

Automated measurement of tracheal and main bronchial diameters: a feasibility study.

BACKGROUND: A thoracic computed tomography scan is rarely used to help choose the appropriate double-lumen tube. Nowadays, bronchial measurements can be automated using dedicated software. The aim of this prospective monocentric study was to compare manual and automated measurements of the diameter of the trachea and both main bronchi in adult patients free from a history of lung surgery or disease. METHODS: Diameters of the trachea and of the main stem bronchi were measured by trained physicians or automatically using Thoracic Volume Computer Assisted Reading software (GE Healthcare, Chicago, IL, USA). Manual measurements were considered as the goal standard. RESULTS: Two hundred and forty-three patients were assessed for eligibility, 216 were allocated to intervention and 173 analyzed: 102 males and 71 females (61.4±13.9 years, 169.7±9.4 cm, 73.3±16.8 kg). Reliability between the two investigators was poor (20.8±9.0% of measurements with a difference >10%). Intraclass correlation coefficient (ICC) and its confidence interval at 95% (ICC [95% CI]) was 0.97 [0.96; 0.98] for the maximal diameter and 0.94 [0.92; 0.95] for the minimal diameter of the trachea (P<0.01 for both). ICC [95% CI] was 0.97 [0.94; 0.98] for the maximal diameter and 0.93 [0.90; 0.95] for the minimal diameter of the right main bronchus (P<0.01 for both). ICC [95% CI] was 0.96 [0.95; 0.97] for the maximal diameter and 0.93 [0.90; 0.95] for the minimal diameter of the left main bronchus (P<0.01 for both). CONCLUSIONS: This feasibility study has mixed results since automated measurements were not feasible in around 20% of the cases.

Exploiting mitochondrial and oxidative vulnerabilities with a synthetic analog of pancratistatin in combination with piperlongumine for cancer therapy.

Harsh adverse effects as a result of nonspecific targeting of chemotherapeutics currently pose obstacles in cancer therapy; thus, it would be invaluable to devise novel approaches to specifically target cancer cells. The natural compound pancratistatin (PST) has been shown to preferentially induce apoptosis in a variety of cancer cell types. Recently, several analogs of PST were shown to be efficacious in inducing apoptosis in a variety of aggressive cancer cell types via cancer cell mitochondrial targeting; it caused dissipation of mitochondrial membrane potential and decreased oxygen consumption, and with isolated mitochondria, it induced the release of apoptogenic factors. The natural compound piperlongumine has been shown to target the stress response to reactive oxygen species in cancer cells. We explored the combinatorial potential of two small molecules (SVTH-6 and piperlongumine) that target these vulnerabilities in cancer cells. Interestingly, when combined with the PST analog, SVTH-6, an increase in mitochondrial dysfunction was observed, leading to an enhanced cytotoxic effect against several human cancer cell types. Additionally, this combination treatment was effective in reducing cancer cell growth in physiologically more relevant 3-dimensional spheroid cell cultures. This enhanced effect was found to be dependent on reactive oxygen species generation because an antioxidant could rescue cancer cells from this combination treatment. Importantly, noncancerous cells were markedly less sensitive to this combination treatment. Thus, targeting mitochondrial and oxidative stress vulnerabilities of cancer cells could be an effective strategy for cancer therapy.-Ma, D., Gilbert, T., Pignanelli, C., Tarade, D., Noel, M., Mansour, F., Gupta, M., Ma, S., Ropat, J., Curran, C., Vshyvenko, S., Hudlicky, T., Pandey. S. Exploiting mitochondrial and oxidative vulnerabilities with a synthetic analog of pancratistatin in combination with piperlongumine for cancer therapy.

HIV incidence in a cohort of women at higher risk in Beira, Mozambique: prospective study 2009-2012.

BACKGROUND: HIV is prevalent in Sofala Province, Mozambique. To inform future prevention research, we undertook a study in the provincial capital (Beira) to measure HIV incidence in women at higher risk of HIV and assess the feasibility of recruiting and retaining them as research participants. METHODS: Women age 18-35 were recruited from schools and places where women typically meet potential sexual partners. Eligibility criteria included HIV-seronegative status and self-report of at least 2 sexual partners in the last month. History of injection drug use was an exclusion criterion, but pregnancy was not. Participants were scheduled for monthly follow-up for 12 months, when they underwent face-to-face interviews, HIV counseling and testing, and pregnancy testing. RESULTS: 387 women were eligible and contributed follow-up data. Most were from 18-24 years old (median 21). Around one-third of participants (33.8%) reported at least one new sexual partner in the last month. Most women (65.5%) reported not using a modern method of contraception at baseline. Twenty-two women seroconverted for a prospective HIV incidence of 6.5 per 100 woman-years (WY; 95% confidence interval (CI): 4.1-9.9). Factors associated with HIV seroconversion in the multivariable analysis were: number of vaginal sex acts without using condoms with partners besides primary partner in the last 7 days (hazard ratio (HR) 1.7; 95% CI: 1.2-2.5) and using a form of contraception at baseline other than hormonal or condoms (vs. no method; HR 25.3; 95% CI: 2.5-253.5). The overall retention rate was 80.0% for the entire follow-up period. CONCLUSIONS: We found a high HIV incidence in a cohort of young women reporting risky sexual behavior in Beira, Mozambique. HIV prevention programs should be strengthened. Regular HIV testing and condom use should be encouraged, particularly among younger women with multiple sexual partners.