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Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study.

ABSTRACT: INTRODUCTION:Peripheral vascular disease (PVD) is a condition caused by arterial blockages causing inadequate blood flow, resulting in pain and gangrene of the legs. Endovascular therapy, such as angioplasty, can be used to treat PVD, however, the operator feedback during surgery is primarily anatomic based on the angiogram. Because physiologic blood perfusion can be difficult to determine based on anatomic images, we propose introducing physiological measurements into the operating room. This study will investigate whether the change in intraoperative monitoring of haemodynamic measurements such as the Toe-Brachial Index during endovascular surgery for lower extremity atherosclerotic PVD is associated with clinical outcomes such as major adverse limb events (MALEs). METHODS AND ANALYSIS:This study will be a prospective, operator-blinded and blinded endpoint adjudicated observational diagnostic cohort study. A total of 80 legs will be enrolled in the study. Ankle and toe blood pressures will be measured non-invasively at predetermined time points before, during and after surgery, and we will assess associations between changes in intraoperative pressure measurements and postoperative clinical and haemodynamic outcomes. The primary outcome will be MALE within 1?year, and secondary outcomes include follow-up pressure measurements, vessel patency, reintervention, clinical staging improvement, amputation and death. ETHICS AND DISSEMINATION:Regional hospital ethics approval has been granted (Ottawa Hospital Research Institute - Research Ethics Board, Protocol 20180656-01H). On completion of data analysis, the study will submitted for presentation at international vascular surgical society meetings, in addition to submission for publication in publicly accessible medical journals. TRIAL REGISTRATION NUMBER:NCT03875846.

SUBMITTER: Rockley M

PROVIDER: S-EPMC6707646 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study.

Rockley Mark M Jetty Prasad P Wells George A GA

BMJ open 20190822 8

<h4>Introduction</h4>Peripheral vascular disease (PVD) is a condition caused by arterial blockages causing inadequate blood flow, resulting in pain and gangrene of the legs. Endovascular therapy, such as angioplasty, can be used to treat PVD, however, the operator feedback during surgery is primarily anatomic based on the angiogram. Because physiologic blood perfusion can be difficult to determine based on anatomic images, we propose introducing physiological measurements into the operating room ...[more]

PMID: 31444190

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Project description:Intracranial pressure (ICP) monitoring is widely used in the management of patients with severe traumatic brain injury (TBI). However, there is limited evidence about the efficacy of ICP monitoring in older subjects (aged ≥65 years). This study evaluated the effect of intraventricular ICP monitoring on the outcome of older adults suffering from a severe TBI.This prospective, observational study included 166 older TBI patients (aged ≥65 years) with Glasgow Coma scale (GCS) scores lower than 9 at admission. The study cohort was divided into two groups, intraventricular ICP monitoring and non-ICP monitoring. The primary outcome was in-hospital mortality. The secondary outcomes included the Glasgow Outcome Scale (GOS) score 6 months after injury, the ICU and total hospital lengths of stay, and mechanical ventilation days.There were 80 patients in the intraventricular ICP monitoring group and 86 patients in non-ICP monitoring group. There was no statistical difference between groups in demographics and severity of head injury. Patients treated with intraventricular ICP monitoring had lower in-hospital mortality (33.8 % vs 51.2 %, P < 0.05), a higher 6-month GOS score (3.0 ± 1.4 vs 2.5 ± 1.2 P < 0.05), and a lower dosage (514 ± 246 g vs 840 ± 323 g, P < 0.0001) and shorter duration (7.2 ± 3.6 days vs 8.4 ± 4.3 days, P < 0.01) of mannitol use. However, the ICU length of stay (14.3 ± 6.4 days vs 11.6 ± 5.8 days, P < 0.01) and mechanical ventilation days (6.7 ± 3.5 days vs 5.6 ± 2.4 days, P < 0.05) were longer in the ICP monitoring group. The total length of hospital stay did not differ between the two groups (28.5 ± 12.1 days vs 26.1 ± 13.5 days, P = 0.23).Intraventricular ICP monitoring may have beneficial effects on the decreased in-hospital mortality and improved 6-month outcome of older patients with severe TBI. However, given that this was an observational study conducted in a single institution, further well-designed randomized control trials are needed to evaluate the effect of intraventricular ICP monitoring on the outcome of older severe TBI patients.

Project description:BACKGROUND:Until now, the prognostic value of microcirculatory alterations in critically ill patients has been mainly evaluated in highly selected subgroups. Aim of this study is to monitor the microcirculation daily in mixed group of Intensive Care Unit (ICU)-patients and to establish the association between (the evolution of) microcirculatory alterations and outcome. METHODS:This is a prospective longitudinal observational single-centre study in adult patients admitted to a 12-bed ICU in an Italian teaching hospital. Sublingual microcirculation was evaluated daily, from admission to discharge/death, using Sidestream Dark Field imaging. Videos were analysed offline to assess flow and density variables. Laboratory and clinical data were recorded simultaneously. A priori, a Microvascular Flow Index (MFI) < 2.6 was defined as abnormal. A binary logistic regression analysis was performed to evaluate the association between microcirculatory variables and outcomes; a Kaplan-Meier survival curve was built. Outcomes were ICU and 90-day mortality. RESULTS:A total of 97 patients were included. An abnormal MFI was present on day 1 in 20.6%, and in 55.7% of cases during ICU admission. Patients with a baseline MFI < 2.6 had higher ICU, in-hospital and 90-day mortality (45 vs. 15.6%, p = 0.012; 55 vs. 28.6%, p = 0.035; 55 vs. 26%, p = 0.017, respectively). An independent association between baseline MFI < 2.6 and outcome was confirmed in a binary logistic analysis (odds ratio 4.594 [1.340-15.754], p = 0.015). A heart rate (HR) ≥ 90 bpm was an adjunctive predictor of mortality. However, a model with stepwise inclusion of mean arterial pressure < 65 mmHg, HR ≥ 90 bpm, lactate > 2 mmol/L and MFI < 2.6 did not detect significant differences in ICU mortality. In case an abnormal MFI was present on day 1, ICU mortality was significantly higher in comparison with patients with an abnormal MFI after day 1 (38 vs. 6%, p = 0.001), indicating a time-dependent significant difference in prognostic value. CONCLUSIONS:In a general ICU population, an abnormal microcirculation at baseline is an independent predictor for mortality. In this setting, additional routine daily microcirculatory monitoring did not reveal extra prognostic information. Further research is needed to integrate microcirculatory monitoring in a set of commonly available hemodynamic variables. Trial registration NCT 02649088, www.clinicaltrials.gov . Date of registration: 23 December 2015, retrospectively registered.

Project description:The interest in perioperative lung protective ventilation has been increasing. However, optimal management during one-lung ventilation (OLV) remains undetermined, which not only includes tidal volume (VT) and positive end-expiratory pressure (PEEP) but also inspired oxygen fraction (FIO2). We aimed to investigate current practice of intraoperative ventilation during OLV, and analyze whether the intraoperative ventilator settings are associated with postoperative pulmonary complications (PPCs) after thoracic surgery.We performed a prospective observational two-center study in Japan. Patients scheduled for thoracic surgery with OLV from April to October 2014 were eligible. We recorded ventilator settings (FIO2, VT, driving pressure (?P), and PEEP) and calculated the time-weighted average (TWA) of ventilator settings for the first 2 h of OLV. PPCs occurring within 7 days of thoracotomy were investigated. Associations between ventilator settings and the incidence of PPCs were examined by multivariate logistic regression.We analyzed perioperative information, including preoperative characteristics, ventilator settings, and details of surgery and anesthesia in 197 patients. Pressure control ventilation was utilized in most cases (92%). As an initial setting for OLV, an FIO2 of 1.0 was selected for more than 60% of all patients. Throughout OLV, the median TWA FIO2 of 0.8 (0.65-0.94), VT of 6.1 (5.3-7.0) ml/kg, ?P of 17 (15-20) cm H2O, and PEEP of 4 (4-5) cm H2O was applied. Incidence rate of PPCs was 25.9%, and FIO2 was independently associated with the occurrence of PPCs in multivariate logistic regression. The adjusted odds ratio per FIO2 increase of 0.1 was 1.30 (95% confidence interval: 1.04-1.65, P =?0.0195).High FIO2 was applied to the majority of patients during OLV, whereas low VT and slight degree of PEEP were commonly used in our survey. Our findings suggested that a higher FIO2 during OLV could be associated with increased incidence of PPCs.

Project description:BackgroundTimely recognition of patient deterioration remains challenging. Ambulatory monitoring systems (AMSs) may provide support to current monitoring practices; however, they need to be thoroughly tested before implementation in the clinical environment for early detection of deterioration.ObjectiveThe objective of this study was to assess the wearability of a selection of commercially available AMSs to inform a future prospective study of ambulatory vital sign monitors in an acute hospital ward.MethodsFive pulse oximeters (4 with finger probes and 1 wrist-worn only, collecting pulse rates and oxygen saturation) and 2 chest patches (collecting heart rates and respiratory rates) were selected to be part of this study: The 2 chest-worn patches were VitalPatch (VitalConnect) and Peerbridge Cor (Peerbridge); the 4 wrist-worn devices with finger probe were Nonin WristOx2 3150 (Nonin), Checkme O2+ (Viatom Technology), PC-68B, and AP-20 (both from Creative Medical); and the 1 solely wrist-worn device was Wavelet (Wavelet Health). Adult participants wore each device for up to 72 hours while performing usual "activities of daily living" and were asked to score the perceived exertion and perception of pain or discomfort by using the Borg CR-10 scale; thoughts and feelings caused by the AMS using the Comfort Rating Scale (CRS); and to provide general free text feedback. Median and IQRs were reported and nonparametric tests were used to assess differences between the devices' CRS scores.ResultsQuantitative scores and feedback were collected in 70 completed questionnaires from 20 healthy volunteers, with each device tested approximately 10 times. The Wavelet seemed to be the most wearable device (P<.001) with an overall median (IQR) CRS score of 1.00 (0.88). There were no statistically significant differences in wearability between the chest patches in the CRS total score; however, the VitalPatch was superior in the Attachment section (P=.04) with a median (IQR) score of 3.00 (1.00). General pain and discomfort scores and total percentage of time worn are also reflective of this.ConclusionsOur results suggest that adult participants prefer to wear wrist-worn pulse oximeters without a probe compressing the fingertip and they prefer to wear a smaller chest patch. A compromise between wearability, reliability, and accuracy should be made for successful and practical integration of AMSs within the hospital environment.

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Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study.

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Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study.

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