Evaluation of Mask-Induced Cardiopulmonary Stress: A Randomized Crossover Trial.
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ABSTRACT:
SUBMITTER: Bao R
PROVIDER: S-EPMC10257095 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
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Evaluation of Mask-Induced Cardiopulmonary Stress: A Randomized Crossover Trial.
Bao Riqiang R Ning Guang G Sun Yingkai Y Pan Shijia S Wang Weiqing W
JAMA network open 20230601 6
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Project description:BackgroundLaryngeal tube (LT) application by rescue personnel as an alternate airway during the early stages of out-of-hospital cardiac arrest (OHCA) is still subject of debate. We evaluated ease of handling and efficacy of ventilation administered by emergency medical technicians (EMTs) using LT and bag-valve-mask (BVM) during cardiopulmonary resuscitation of patients with OHCA.MethodsAn open prospective randomized multicenter study was conducted at six emergency medical services centers over 18 months. Patients in OHCA initially resuscitated by EMTs were enrolled. Ease of handling (LT insertion, tight seal) and efficacy of ventilation (chest rises visibly, no air leak) with LT and BVM were subjectively assessed by EMTs during pre-study training and by the attending emergency physician on the scene. Outcome and frequency of complications were compared.ResultsOf 97 eligible patients, 78 were enrolled. During pre-study training EMTs rated efficacy of ventilation with LT higher than with BVM (66.7% vs. 36.2%, p = 0.022), but efficacy of on-site ventilation did not differ between the two groups (71.4% vs. 58.5%, p = 0.686). Frequency of complications (11.4% vs. 19.5%, p = 0.961) did not differ between the two groups.ConclusionsEMTs preferred LT ventilation to BVM ventilation during pre-study training, but on-site there was no difference with regard to efficacy, ventilation safety, or outcome. The results indicate that LT ventilation by EMTs during OHCA is not superior to BVM and cannot substitute for BVM training. We assume that the main benefit of the LT is the provision of an alternative airway when BVM ventilation fails. Training in BVM ventilation remains paramount in EMT apprenticeship and cannot be substituted by LT ventilation.Trial registrationClinicalTrials.gov (NCT01718795).
| S-EPMC5658918 | biostudies-literature
Project description: Not available
| S-EPMC8246308 | biostudies-literature
Project description:BACKGROUND:Indoor exposure to fine particulate matter (PM2.5) from outdoor sources is a major health concern, especially in highly polluted developing countries such as China. Few studies have evaluated the effectiveness of indoor air purification on the improvement of cardiopulmonary health in these areas. OBJECTIVES:This study sought to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health. METHODS:We conducted a randomized, double-blind crossover trial among 35 healthy college students in Shanghai, China, in 2014. These students lived in dormitories that were randomized into 2 groups and alternated the use of true or sham air purifiers for 48 h with a 2-week washout interval. We measured 14 circulating biomarkers of inflammation, coagulation, and vasoconstriction; lung function; blood pressure (BP); and fractional exhaled nitric. We applied linear mixed-effect models to evaluate the effect of the intervention on health outcome variables. RESULTS:On average, air purification resulted in a 57% reduction in PM2.5 concentration, from 96.2 to 41.3 μg/m3, within hours of operation. Air purification was significantly associated with decreases in geometric means of several circulating inflammatory and thrombogenic biomarkers, including 17.5% in monocyte chemoattractant protein-1, 68.1% in interleukin-1β, 32.8% in myeloperoxidase, and 64.9% in soluble CD40 ligand. Furthermore, systolic BP, diastolic BP, and fractional exhaled nitrous oxide were significantly decreased by 2.7%, 4.8%, and 17.0% in geometric mean, respectively. The impacts on lung function and vasoconstriction biomarkers were beneficial but not statistically significant. CONCLUSIONS:This intervention study demonstrated clear cardiopulmonary benefits of indoor air purification among young, healthy adults in a Chinese city with severe ambient particulate air pollution. (Intervention Study on the Health Impact of Air Filters in Chinese Adults; NCT02239744).
| S-EPMC5360574 | biostudies-literature
Project description:BackgroundCardiopulmonary bypass (CPB) causes systemic oxidative stress response and endothelial damage in systemic organs. We investigated the effects of positive end-expiratory pressure (PEEP) and mechanical ventilation (MV) applications on oxidative stress in CPB.MethodsSeventy-one patients were recruited and 60 completed the study. Randomized groups: MV off (Group 1); MV on, tidal volume (TV) at 3-4 mL.kg-1 (Group 2); MV on, TV at 3-4 mL.kg-1, PEEP at 5 cmH2O (Group 3), n = 20 in each group. As oxidative stress markers, we used glutathione peroxidase (GPx), total antioxidant status (TAS), total oxidant status (TOS), total and native thiol (TT, NT), malondialdehyde (MDA), and catalase. We also investigated the correlation between oxidative stress and postoperative intubation time.ResultsThe postoperative GPx levels in Group 2 were higher than Group 3 (p = 0.017). In groups 2 and 3, TAS levels were higher postoperatively than intraoperatively (p = 0.001, p = 0.019, respectively). In Group 2, the TT levels were higher postoperatively than preoperatively and intraoperatively (p = 0.008). In Group 3, the postoperative MDA levels were higher than preoperatively (p = 0.001) and were higher than both postoperative levels of Group 1 and 2 (p = 0.043, p = 0.003). As the preoperative TAS (Group 2) decreased and the postoperative NT (Group 2) and catalase (Group 3) increased, the postoperative intubation time lengthened.ConclusionMV ( 3-4 mL.kg-1) alone seems to be the most advantageous strategy. Prolonged postoperative intubation time was associated with both increased NT and catalase levels.
| S-EPMC9373507 | biostudies-literature
Project description:Green exercise, defined as physical activity in natural environments, might have positive effects on stress-related physiological measures. Little is known about the acute effects of green exercise bouts lasting longer than 60 min. Therefore, the aim of the present study was to analyze the acute effects of a three-hour green exercise intervention (mountain hiking) on stress-related physiological responses. Using a randomized crossover design, 42 healthy participants were exposed to three different conditions in a field-based experiment: outdoor mountain hiking, indoor treadmill walking, and sedentary control condition (three hours each). At baseline and at follow-up (five minutes after the condition), stress-related physiological responses (salivary cortisol, blood pressure, and heart rate variability) were measured. Salivary cortisol decreased in all conditions, but showed a larger decrease after both mountain hiking and treadmill walking compared to the sedentary control situation (partial η² = 0.10). No differences were found between mountain hiking and treadmill walking in salivary cortisol. In heart rate variability and blood pressure, changes from baseline to follow-up did not significantly differ between the three conditions. The results indicate that three hours of hiking indoors or outdoors elicits positive effects on salivary cortisol concentration. Environmental effects seem to play a minor role in salivary cortisol, blood pressure, and heart rate variability.
| S-EPMC5580608 | biostudies-literature
Project description:Background: Automated insulin delivery (AID) systems have not been evaluated in the context of psychological and pharmacological stress in type 1 diabetes. Our objective was to determine glycemic control and insulin use with Zone Model Predictive Control (zone-MPC) AID system enhanced for states of persistent hyperglycemia versus sensor-augmented pump (SAP) during outpatient use, including in-clinic induced stress. Materials and Methods: Randomized, crossover, 2-week trial of zone-MPC AID versus SAP in 14 adults with type 1 diabetes. In each arm, each participant was studied in-clinic with psychological stress induction (Trier Social Stress Test [TSST] and Socially Evaluated Cold Pressor Test [SECPT]), followed by pharmacological stress induction with oral hydrocortisone (total four sessions per participant). The main outcomes were 2-week continuous glucose monitor percent time in range (TIR) 70-180 mg/dL, and glucose and insulin outcomes during and overnight following stress induction. Results: During psychological stress, AID decreased glycemic variability percentage by 13.4% (P = 0.009). During pharmacological stress, including the following overnight, there were no differences in glucose outcomes and total insulin between AID and physician-assisted SAP. However, with AID total user-requested insulin was lower by 6.9 U (P = 0.01) for pharmacological stress. Stress induction was validated by changes in heart rate and salivary cortisol levels. During the 2-week AID use, TIR was 74.4% (vs. SAP 63.1%, P = 0.001) and overnight TIR was 78.3% (vs. SAP 63.1%, P = 0.004). There were no adverse events. Conclusions: Zone-MPC AID can reduce glycemic variability and the need for user-requested insulin during pharmacological stress and can improve overall glycemic outcomes. Clinical Trial Identifier NCT04142229.
| S-EPMC9271334 | biostudies-literature
Project description:A safe way of securing the airway with an endotracheal tube is one of the priorities of an advanced cardiovascular life support algorithm for suspected or confirmed COVID-19 patients. The aim of this study was to compare intubation success rates (ISR) and intubation time (IT) of different laryngoscopes for simulated COVID-19 patients under cardiopulmonary resuscitation. The study was designed as a prospective, randomized, crossover trial. Fifty four active paramedics performed endotracheal intubation with a Macintosh direct laryngoscope (MAC) and McGrath videolaryngoscope (McGrath) with and without personal protective equipment (PPE). Without PPE, ISRs were 87% and 98% for MAC and McGrath, respectively (p = 0.32). ITs were 22.5 s (IQR: 19-26) and 19.5 s (IQR: 17-21) for MAC and McGrath, respectively (p = 0.005). With PPE, first-pass ISR were 30% and 89% with MAC and McGrath, respectively (p < 0.001). The overall success rates were 83% vs. 100% (p = 0.002). Median ITs were 34.0 s (IQR: 29.5-38.5) and 24.8 s (IQR: 21-29) for MAC and McGrath, respectively (p < 0.001). In conclusion, the McGrath videolaryngoscope appears to possess significant advantages over the Macintosh direct laryngoscope when used by paramedics in suspected or confirmed COVID-19 intubation scenarios.
| S-EPMC8707195 | biostudies-literature
Project description:Importance:Tear film breakup time assessment is an integral component of dry eye evaluation. To our knowledge, the comparative discriminative ability of the noninvasive Keratograph (Oculus) vs conventional fluorescein method in detecting dry eye is unknown. Objective:To compare tear film stability measurements obtained with an automated noninvasive corneal topographer vs conventional fluorescein methods and evaluate their respective discriminative ability in detecting dry eye. Design, Setting, and Participants:This investigator-masked randomized crossover trial was conducted at a single-center university clinic between May 26, 2016, and October 3, 2016, and included 74 participants 18 years or older. Participants were recruited into 2 equally sized age, sex, and race/ethnicity-matched groups, with and without symptomatic dry eye (Ocular Surface Disease Index ≥13). Interventions:Participants were assigned to receive a noninvasive keratograph evaluation and topical fluorescein instillation in a randomized order. Main Outcomes and Measures:Noninvasive keratograph breakup time (NIKBUT) and fluorescein breakup time (TBUT). Area under the receiver operating characteristic curve, Youden-optimal diagnostic cutoff sensitivity, and specificity of NIKBUT and TBUT in detecting dry eye. Results:Seventy-four participants (74 eyes; 43 women [58.1%]) with a mean (SD) age of 24 (4) years were randomized. Noninvasive keratograph breakup time was significantly longer than TBUT in participants with dry eye (median, 6.3 seconds vs 4.3 seconds [difference, 2.0 seconds]; 95% CI, 1.1-3.4 seconds; P = .003), and healthy participants (median, 11.9 seconds vs 5.0 seconds [difference, 6.9 seconds]; 95% CI, 4.7-7.6 seconds; P < .001). Fluorescein breakup time measurements were more narrowly distributed in both the dry eye (variance, 188 seconds2 vs 27.9 seconds2; P < .001) and control groups (variance, 113 seconds2 vs 13.4 seconds2; P < .001). The discriminative ability of NIKBUT in detecting dry eye (area under the receiver operating characteristic curve, 0.68; 95% CI, 0.56-0.81; P = .007) was greater than that of TBUT (area under the receiver operating characteristic curve, 0.57; 95% CI, 0.44-0.70; P = .31). The optimal diagnostic cutoff for NIKBUT was 9 seconds or less with a sensitivity of 68% (95% CI, 50%-82%), specificity of 70% (95% CI, 53%-84%), positive likelihood ratio of 2.27 (95% CI, 1.32-3.91), and negative likelihood ratio of 0.46 (95% CI, 0.28-0.77). The optimal threshold for TBUT was 5 seconds or less with a sensitivity of 54% (95% CI, 37%-71%), specificity of 68% (95% CI, 50%-82%), positive likelihood ratio of 1.67 (95% CI, 0.96-2.89), and negative likelihood ratio of 0.68 (95% CI, 0.45-1.03). Conclusions and Relevance:Conventional fluorescein tear film breakup time measurements were significantly shorter with narrower distributions, while automated noninvasive keratograph readings displayed superior discriminative ability in detecting dry eye. Trial Registration:anzctr.org.au Identifier: ACTRN12617001428358.
| S-EPMC5885903 | biostudies-literature
Project description:BackgroundMusculoskeletal conditions account for 16% of global disability, resulting in a negative effect on patients and increasing demand for health care use. Triage directing patients to appropriate level intervention improving health outcomes and efficiency has been prioritized. We developed a musculoskeletal digital assessment routing tool (DART) mobile health (mHealth) system, which requires evaluation prior to implementation. Such innovations are rarely rigorously tested in clinical trials-considered the gold standard for evaluating safety and efficacy. This pilot study is a precursor to a trial assessing DART performance with a physiotherapist-led triage assessment.ObjectiveThe study aims to evaluate trial design, assess procedures, and collect exploratory data to establish the feasibility of delivering an adequately powered, definitive randomized trial, assessing DART safety and efficacy in an NHS primary care setting.MethodsA crossover, noninferiority pilot trial using an integrated knowledge translation approach within a National Health Service England primary care setting. Participants were patients seeking assessment for a musculoskeletal condition, completing a DART assessment and the history-taking element of a face-to-face physiotherapist-led triage in a randomized order. The primary outcome was agreement between DART and physiotherapist triage recommendation. Data allowed analysis of participant recruitment and retention, randomization, blinding, study burden, and potential barriers to intervention delivery. Participant satisfaction was measured using the System Usability Scale.ResultsOver 8 weeks, 129 patients were invited to participate. Of these, 92% (119/129) proceeded to eligibility assessment, with 60% (78/129) meeting the inclusion criteria and being randomized into each intervention arm (39/39). There were no dropouts and data were analyzed for all 78 participants. Agreement between physiotherapist and DART across all participants and all primary triage outcomes was 41% (32/78; 95% CI 22-45), intraclass correlation coefficient 0.37 (95% CI 0.16-0.55), indicating that the reliability of DART was poor to moderate. Feedback from the clinical service team led to an adjusted analysis yielding of 78% (61/78; 95% CI 47-78) and an intraclass correlation coefficient of 0.57 (95% CI 0.40-0.70). Participant satisfaction was measured quantitively using amalgamated System Usability Scale scores (n=78; mean score 84.0; 90% CI +2.94 to -2.94), equating to an "excellent" system. There were no study incidents, and the trial burden was acceptable.ConclusionsPhysiotherapist-DART agreement of 78%, with no adverse triage decisions and high patient satisfaction, was sufficient to conclude DART had the potential to improve the musculoskeletal pathway. Study validity was enhanced by the recruitment of real-world patients and using an integrated knowledge translation approach. Completion of a context-specific consensus process is recommended to provide definitive definitions of safety criteria, range of appropriateness, noninferiority margin, and sample size. This pilot demonstrated an adequately powered definitive trial is feasible, which would provide evidence of DART safety and efficacy, ultimately informing potential for DART implementation.Trial registrationClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029.International registered report identifier (irrid)RR2-10.2196/31541.
| S-EPMC11322692 | biostudies-literature
Project description:BackgroundLancet pricks are often poorly received by individuals with diabetes; jet injection may allow lancet-free blood sampling. We examine whether the technique of jet injection can release sufficient blood from the fingertip to enable measurement of blood glucose concentration. In addition, we assess the effect of jet shape and cross-sectional area on fluid release, blood dilution, and perceived pain.MethodsA randomized, single-blind, crossover study was conducted on 20 healthy volunteers who received interventions on four fingertips: a lancet prick, and jet injection of a small quantity of saline solution through three differently shaped and sized nozzles. Released fluid volume, blood concentration, and glucose concentration were assessed immediately after the intervention. Pain perception and duration, and any skin reactions, were evaluated both immediately and 24 hours after the intervention.ResultsJet injection released sufficient blood from the fingertip to conduct a glucose measurement. A slot-shaped nozzle released the most blood, although less than a lancet, with slightly higher pain. The blood glucose levels estimated from the extracted fluid showed a mean absolute percentage error of 25%. There was no consistent evidence that a jet injection leads to different skin reactions at the intervention site relative to a lancet prick.ConclusionsFingertip penetration by jet injection can release a volume of fluid sufficient for blood glucose measurement. Jet injection with a slot-shaped nozzle and/or a nozzle with larger outlet area helps to release more fluid. This technique may enable blood sampling, glucose concentration measurement, and insulin delivery to be performed in a single device.
| S-EPMC10012351 | biostudies-literature