scholarly journals Effectiveness of a continuous patient position monitoring system in improving hospital turn protocol compliance in an ICU: A multiphase multisite study in India

2018 ◽  
Vol 20 (4) ◽  
pp. 309-315 ◽  
Author(s):  
BS Renganathan ◽  
Sridhar Nagaiyan ◽  
SP Preejith ◽  
Shameer Gopal ◽  
Susovan Mitra ◽  
...  
Keyword(s):  
Intensive Care ◽  
Phase I ◽  
Monitoring System ◽  
Phase Ii ◽  
Pressure Ulcers ◽  
Control Group ◽  
Study Phase ◽  
Patient Position ◽  
Protocol Compliance ◽  
Position Monitoring

Purpose Hospital-acquired pressure ulcers are a significant cause of morbidity and consume considerable financial resources. Turn protocols (repositioning patients at regular intervals) are utilized to reduce incidence of pressure ulcers. Adherence to turn protocols is particularly challenging for nursing teams, given the high number of interventions in intensive care unit, and lack of widely available tools to monitor patient position and generate alerts. We decided to develop and evaluate usefulness of a continuous patient position monitoring system to assist nurses in improving turn protocol compliance. Methods We conducted a prospective, non-randomized, multiphase, multicentre trial. In Phase I (control group), the function of the device was not revealed to nurses so as to observe their baseline adherence to turn protocol, while Phase II (intervention group) used continuous patient position monitoring system to generate alerts, when non-compliant with the turn protocol. All consecutive patients admitted to one of the two intensive care units during the study period were screened for enrolment. Patients at risk of acquiring pressure ulcers (Braden score < 18) were considered for the study (Phase I (N = 22), Phase II (N = 25)). Results We analysed over 1450 h of patient position data collected from 40 patients (Phase I (N = 20), Phase II (N = 20)). Turn protocol compliance was significantly higher in Phase II (80.15 ± 8.97%) compared to the Phase I (24.36 ± 12.67%); p < 0.001. Conclusion Using a continuous patient position monitoring system to provide alerts significantly improved compliance with hospital turn protocol. Nurses found the system to be useful in providing automated turn reminders and prioritising tasks.

Development and clinical application of a patient-position monitoring system

1994 ◽  
Author(s):  
Lee H. Gerig ◽  
Sabry F. El-Hakim ◽  
Janos Szanto ◽  
Doug Salhani ◽  
A. Girard
Keyword(s):  
Monitoring System ◽  
Clinical Application ◽  
Patient Position ◽  
Position Monitoring

scholarly journals LIPid Intensive Drug therapy for Sepsis Pilot (LIPIDS-P): Phase I/II clinical trial protocol of lipid emulsion therapy for stabilising cholesterol levels in sepsis and septic shock

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029348 ◽  
Author(s):  
Faheem W Guirgis ◽  
Lauren Page Black ◽  
Martin Daniel Rosenthal ◽  
Morgan Henson ◽  
Jason Ferreira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Drug Therapy ◽  
High Density Lipoprotein ◽  
Phase I ◽  
Cholesterol Level ◽  
Phase Ii ◽  
Lipid Emulsion ◽  
Density Lipoprotein ◽  
Control Group ◽  
Cholesterol Levels

IntroductionSepsis is a life-threatening, dysregulated response to infection. Both high-density lipoprotein and low-density lipoprotein cholesterol should protect against sepsis by several mechanisms; however, for partially unknown reasons, cholesterol levels become critically low in patients with early sepsis who experience poor outcomes. An anti-inflammatory lipid injectable emulsion containing fish oil is approved by the Food and Drug Administration as parenteral nutrition for critically ill patients and may prevent this decrease in serum cholesterol levels by providing substrate for cholesterol synthesis and may favourably modulate inflammation. This LIPid Intensive Drug therapy for Sepsis Pilot clinical trial is the first study to attempt to stabilise early cholesterol levels using lipid emulsion as a treatment modality for sepsis.Methods and analysisThis is a two-centre, phase I/II clinical trial. Phase I is a non-randomised dose-escalation study using a Bayesian optimal interval design in which up to 16 patients will be enrolled to evaluate the safest and most efficacious dose for stabilising cholesterol levels. Based on phase I results, the two best doses will be used to randomise 48 patients to either lipid injectable emulsion or active control (no treatment). Twenty-four patients will be randomised to one of two doses of the study drug, while 24 control group patients will receive no drug and will be followed during their hospitalisation. The control group will receive all standard treatments mandated by the institutional sepsis alert protocol. The phase II study will employ a permuted blocked randomisation technique, and the primary endpoint will be change in serum total cholesterol level (48 hours − enrolment). Secondary endpoints include change in cholesterol level from enrolment to 7 days, change in Sequential Organ Failure Assessment score over the first 48 hours and 7 days, in-hospital and 28-day mortality, lipid oxidation status, inflammatory biomarkers, and high-density lipoprotein function.Ethics and disseminationInvestigators are trained and follow good clinical practices, and each phase of the study was reviewed and approved by the institutional review boards of each institution. Results of each phase will be disseminated through presentations at national meetings and publication in peer-reviewed journals. If promising, data from the pilot study will be used for a larger, multicentre, phase II clinical trial.Trial registration numberNCT03405870.

TRC105 for the treatment of hepatocellular carcinoma: Preclinical data and preliminary results from two clinical trials evaluating monotherapy and combination with sorafenib.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 211-211
Author(s):  
Austin G. Duffy ◽  
Chi Ma ◽  
Susanna Varkey Ulahannan ◽  
Suzanne Fioravanti ◽  
Aradhana Venkatesan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Endothelial Cell ◽  
Phase I ◽  
Phase Ii ◽  
Color Doppler ◽  
Single Agent ◽  
Study Phase ◽  
Cerebral Tumor ◽  
Color Flow ◽  
Dce Mri

211 Background: Endoglin (CD105), is an endothelial cell membrane receptor highly expressed on proliferating tumor vasculature, including in HCC. CD105 is essential for angiogenesis and its expression is upregulated by hypoxia and VEGF inhibition. TRC105 is a chimeric IgG1 anti-CD105 monoclonal antibody that acts by endothelial cell growth inhibition, ADCC and apoptosis. Methods: Preclinical: Murine BNL HCC cells were grown subcutaneously in wildtype Balb/c mice and treated with antibody to murine CD105, (clone MJ7/18; 10-200ug) ± sorafenib (10 mg/kg daily p.o.) or sorafenib alone. Clinical: Patients with HCC (Childs Pugh A/B7), ECOG 0/1, were enrolled in a phase I study of TRC105 at 3, 6, 10, 15mg/kg q 2wks plus sorafenib 400mg bid; or (if sorafenib-refractory) a phase II study of TRC105 at 10 or 15mg/kg q 2wks. Correlative biomarkers: DCE-MRI; FDG-PET; color Doppler ultrasonography; circulating endothelial and endothelial progenitor cells, plasma levels of angiogenic factors; soluble CD105 and tumor IHC for CD105. Results: Preclinical studies: CD105 expression was increased in BNL HCC tumors of mice treated with sorafenib. Anti-CD105 + sorafenib was more effective than sorafenib alone. Clinical trials (N=16): M:F 13:3; Median age = 55 (range 24-67); Phase I with sorafenib (N=8): 1 DLT (increased AST) occurred at 10mg/kg. The most frequent toxicity has been epistaxis. One patient with coronary stenosis developed a fatal MI and one patient with thrombocytopenia developed G3 cerebral tumor hemorrhage. Phase II (N=8): No grade 3/4 treatment-related toxicities . Most frequent toxicities headache (G2; N=3) and epistaxis (G1; N=4). No patient was progression free at 4 months. Median time on study: Phase I- 4 months; Phase II - 2 months. Preliminary evidence of biologic response seen on DCE-MRI in 1pt (of 3 evaluable) with a reduction in Ktrans and kep and 3pts (of 3 evaluable) with reduction in intra-tumoral color flow on Doppler. Conclusions: TRC105 is well tolerated both as single agent and combined with sorafenib. Evidence of biological activity was observed. Full preclinical, clinical and correlative data will be presented. Clinical trial information: NCT01306058, NCT01375569.

Intermodal Stimulus Generalization and Retention of Habituation in Earthworms

1978 ◽  
Vol 42 (3) ◽  
pp. 683-690 ◽  
Author(s):  
Andrew R. Gilpin ◽  
Stanley C. Ratner
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
White Light ◽  
Intertrial Interval ◽  
The Other ◽  
Phase Iii ◽  
Stimulus Generalization ◽  
Control Group ◽  
Three Phases

50 mature earthworms ( L. terrestris) were assigned randomly to one of five stimulus conditions in an experiment with three phases. In Phase I Group Light-Vibration-Light received 2-sec. presentations of white light (with an 18-sec. intertrial interval) to an habituation criterion; in Phase II vibration was presented on the same schedule; and in Phase III, which began 2 hr. after the end of Phase I, presentations of light were given. Group Vibration-Light-Vibration received vibration in Phases I and III and light in Phase II; Groups Vibration-Rest-Vibration and Light-Rest-Light received no stimulation in Phase II. A control group was observed on the same schedule but received no stimuli. Results indicated that previous habituation to one stimulus reduced responses to the other stimulus, regardless of the type of stimulation (stimulus generalization). Retention of habituation from Phase I to Phase III was reduced in Group Light-Vibration-Light but not Group Vibration-Light-Vibration, relative to their counterparts receiving rest in Phase II. Thus results indicated that the effects of habituation in this organism depend on the presence of stimuli from other modalities.

scholarly journals Effectivness of the GnRH analogue deslorelin as a reversible contraceptive in a neotropical primate, the Common Marmoset Callithrix Jacchus (Mammalia: Primates: Callitrichidae)

2016 ◽  
Vol 8 (4) ◽  
pp. 8652 ◽  
Author(s):  
Derek A. Rosenfield ◽  
P. Viau ◽  
C. A. Oliveira ◽  
Cristiane Schilbach Pizzutto
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Common Marmoset ◽  
Callithrix Jacchus ◽  
Phase Iii ◽  
Primate Species ◽  
Control Group ◽  
Gnrh Analogue ◽  
Cyclic Activity ◽  
Neotropical Primate

Deslorelin is a synthetic GnRH analogue, which is being used as a contraceptive in animals by acting as a gonadal suppressant.  The product Suprelorin (Virbac, Australia) contains deslorelin as a biocompatible, slow release subcutaneous implant. The continuous release of deslorelin provokes a down-regulation of GnRH receptors, and subsequently, inhibition of the synthesis and release of the gonadotropins FSH and LH, necessary for gonadal activities.  The intention of this study was to investigate the effectiveness of a subcutaneous deslorelin acetate implant (2,35mg) in suppressing ovarian cyclic activity and inhibiting ovulation in captive Common Marmoset Callithrix jacchus, and investigate the reversibility of the treatment.  Two experimental groups were formed, group deslorelin (D) with three couples and control group (C) with two couples.  To monitor the effect of the implants, hormones indicating ovarian cyclic activity were monitored non-invasively by enzyme immunoassay (fecal monoclonal antibody anti-progesterone CL 425).  Fecal samples were collected three times a week from all females during three trial phases (phase I: month 1,2,3 and 4; phase II: month: 5,6 and 7 and phase III: month 8,9 and 10).  In contrast to expectations the results of this trial indicated that there was no suppression of the ovarian cyclic activity, nor inhibition of the ovulation after the application of the implants.  The outcome of our trial can possibly be explained by the fact that the dosage of 2.35mg of deslorelin is not effective in C. jacchus.  We confirmed significant changes (p<0.05) of P4 metabolites from phase I to phase II due to the treatment after the implantation of the GnRH analogue Deslorelin.  The employed non-invasive fecal progesterone monitoring could be biologically validated and proved to be efficient in the detection of ovarian cyclic activity in this neotropical primate species, C. jacchus. 

scholarly journals CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052880
Author(s):  
Tanuja Narayansamy Gengiah ◽  
Quarraisha Abdool Karim ◽  
Ishana Harkoo ◽  
Leila Mansoor ◽  
Nonhlanhla Yende Zuma ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Phase I Trial ◽  
Percentage Change ◽  
African Women ◽  
Control Group ◽  
Health Products ◽  
Tenofovir Alafenamide ◽  
Long Acting ◽  
Hiv Acquisition

IntroductionYoung African women bear a disproportionately high risk for HIV acquisition. HIV technologies that empower women to protect themselves are needed. Safe, potent antiretroviral agents such as tenofovir alafenamide (TAF), formulated as long-acting subdermal implants, offer an innovative solution.Methods and analysisCAPRISA 018 is a phase I/II trial to evaluate the safety, acceptability, tolerability and pharmacokinetics (PKs) of a TAF free base subdermal silicone implant containing 110 mg of TAF with an anticipated 0.25 mg/day release rate.The phase I trial (n=60) will assess the safety of one implant inserted in six participants (Group 1), followed by dose escalation components (Groups 2 and 3) assessing the safety, tolerability and PK of one to four TAF 110 mg implants releasing between 0.25 mg and 1 mg daily in 54 healthy women at low risk for HIV infection. Data from this phase I trial will be used to determine the dosing, implant location and implant replacement interval for the phase II trial.The phase II component (Group 4) will assess extended safety, PK, tolerability and acceptability of the implant in 490 at risk women, randomised in a 1:1 ratio to the TAF implant and placebo tablet or to the placebo implant and an oral pre-exposure prophylaxis tablet. Safety will be assessed by calculating the percentage change in creatinine clearance from baseline at weeks 4, 12, 24, 36, 72, 96 and 120, compared with the percentage change in the control group.Ethics and disseminationThe South African Health Products Regulatory Authority and the University of KwaZulu-Natal’s Biomedical Research Ethics Committee have approved the trial. Results will be disseminated through open access peer reviewed publications, conference presentations, public stakeholder engagement and upload of data into the clinical trials registry.Trial registration numberPACTR201809520959443.

A Multifaceted Strategy to Reduce Inappropriate Use of Fresh Frozen Plasma Transfusions in the Intensive Care Unit.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1412-1412
Author(s):  
Donald M. Arnold ◽  
Heather Whittingham ◽  
Francois Lauzier ◽  
France Clarke ◽  
Ellen McDonald ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Phase I ◽  
Phase Ii ◽  
Fresh Frozen Plasma ◽  
Phase Iii ◽  
Request Form ◽  
Assessment Period ◽  
Fresh Frozen ◽  
Frozen Plasma

Abstract Abstract 1412 Poster Board I-435 Introduction: The overuse of fresh frozen plasma (FFP) transfusions has been well documented, especially among critically ill patients. In a mixed medical surgical intensive care unit (ICU), we documented that 43% of FFP transfusions were given for indications other than those proposed in published guidelines (Lauzier 2007). Methods: We developed a 3-Phase multifaceted behavior-change strategy to curtail inappropriate FFP transfusions, documenting all patients who had FFP, excluding plasmapheresis. Phase I was a 3-month baseline assessment period with no intervention, in which the FFP transfusion orders prescribed at the discretion of the ICU team were recorded. Phase II was a 3-month intervention targeted to all ICU clinicians, comprised of education on the appropriate use of FFP transfusions, audit and feedback of performance indicators, and a pre-order FFP Request Form to specify the indication and the pre-transfusion INR. Phase III was a 9-month assessment period incorporating only the FFP Request Form. At the end of the study, the indications for all transfusions were adjudicated independently in triplicate by 2 ICU clinicians and 1 hematologist, to determine whether each FFP transfusion was a) consistent with published guidelines, b) inconsistent with guidelines but appropriate for the ICU context, or c) inconsistent and inappropriate. Discrepancies were resolved in all cases. FFP orders were not withheld if FFP Request Forms were not completed. Results: Chance-corrected agreement (which considers clustered transfusions within patients) between ICU reviewers on whether transfusions were consistent or appropriate versus inconsistent and inappropriate was high (phi = 0.80). During Phase I (3 months), 66 FFP transfusions were administered (n= 26 patients), of which 30 were for bleeding. During Phase II (3 months), 24 transfusions were administered (n = 11 patients), of which 11 were for bleeding. During Phase III (7 months of data), 96 transfusions were given (n= 41 patients), of which 57 were for bleeding. Rates of FFP transfusions per month for all indications and for bleeding indications were 22 and 10, respectfully in Phase I; 8 and 4 in Phase II; and 14 and 8 in Phase III. A FFP Request form accompanied 39 (40.6%) of 96 FFP transfusions in Phase III. Conclusions: A multifaceted behavior-change strategy appears to be an effective method of changing inappropriate FFP transfusion practices; however satisfactory uptake of a pre-transfusion FFP Request Form requires consistent reminders. We recommend that transfusion guidelines are improved to explicitly incorporate FFP transfusion criteria appropriate for the ICU setting. Disclosures: No relevant conflicts of interest to declare.

Growth hormone decreases phase II ventricular tachyarrhythmias during acute myocardial infarction in rats

2007 ◽  
Vol 112 (7) ◽  
pp. 385-391 ◽  
Author(s):  
Dimitrios A. Elaiopoulos ◽  
Dimitrios G. Tsalikakis ◽  
Maria G. Agelaki ◽  
Giannis G. Baltogiannis ◽  
Agathokleia C. Mitsi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Growth Hormone ◽  
Phase I ◽  
Infarct Size ◽  
Phase Ii ◽  
Ventricular Tachyarrhythmia ◽  
Left Ventricular ◽  
Monophasic Action Potential ◽  
Control Group ◽  
Coronary Artery Ligation

GH (growth hormone) administration during acute MI (myocardial infarction) ameliorates subsequent LV (left ventricular) dysfunction. In the present study, we examined the effects of such treatment on arrhythmogenesis. A total of 53 Wistar rats (218±17 g) were randomized into two groups receiving two intraperitoneal injections of either GH (2 international units/kg of body weight; n=26) or normal saline (n=27), given at 24 h and 30 min respectively, prior to MI, which was generated by left coronary artery ligation. A single-lead ECG was recorded for 24 h post-MI, using an implanted telemetry system. Episodes of VT (ventricular tachyarrhythmia) and VF (ventricular fibrillation) during the first hour (phase I) and the hours following (phase II) MI were analysed. Monophasic action potential was recorded from the lateral LV epicardium at baseline and 24 h post-MI, and APD90 (action duration at 90% of repolarization) was measured. Infarct size was calculated 24 h post-MI. Infarct size and phase I VT+VF did not differ significantly between groups, but phase II hourly duration of VT+VF episodes was 82.8±116.6 s/h in the control group and 18.3±41.2 s/h in the GH group (P=0.0027), resulting in a lower arrhythmic (P=0.016) and total (P=0.0018) mortality in GH-treated animals. Compared with baseline, APD90 was prolonged significantly 24 h post-MI in the control group, displaying an increased beat-to-beat variation, but remained unchanged in the GH group. We conclude that GH decreases phase II VTs during MI in the rat. This finding may have implications in cardiac repair strategies.

Variable angle stereo imaging for rapid patient position correction in an in-house real-time position monitoring system

2017 ◽  
Vol 33 ◽  
pp. 170-178 ◽  
Author(s):  
Sankar Arumugam ◽  
Mark Sidhom ◽  
Daniel Truant ◽  
Aitang Xing ◽  
Mark Udovitch ◽  
...  
Keyword(s):  
Real Time ◽  
Monitoring System ◽  
Stereo Imaging ◽  
Patient Position ◽  
Variable Angle ◽  
Position Correction ◽  
Time Position ◽  
Position Monitoring

A Study on Methodology to Make Team: Methodology — Phase II

2017 ◽  
Author(s):  
Yoichi Sugimoto ◽  
Masao Arakawa ◽  
Masahiko Ishimaru
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Layer Structure ◽  
Intervention Group ◽  
Phase Iii ◽  
Control Group ◽  
Team Management ◽  
Group Randomized Trials ◽  
Parallel Group ◽  
Study Results

Improvement in labor productivity is a common problem in each country. In particular, in Japan where the productive age population is decreasing, it is necessary to steadily advance efforts for the improvement at various sites throughout the entire society. In doing so, in order to make it prevail over broad areas, it is necessary to consider that on-site holding resources can be utilized, that it can be easily introduced, and that it will surely be effective. Therefore, we have focused on improving the way of collaboration from an angle of “person’s personality”. Specifically, we have aimed to build a methodology, for a “team” that is a collaborative form widely introduced and utilized at companies and educational sites, which enhances the effectiveness of team activities. As for the overall structure of the methodology, we have designed it with a three-layer structure in order to clarify separation from other intellectual properties and consideration to ethical aspects. That is, the designed methodology comprises the following three phases. Phase I: a team formation methodology; Phase II: a team management methodology; and Phase III: a team development support methodology. Study results of Phase I were presented at the 26th Design Engineering and System Division Lecture by the Japan Society of Mechanical Engineers (JSME). In this study, we have used the methodology of Phase I to devise, as a method included in Phase II, three Rules for creating a team environment that makes it easy for “introverted” persons in Jungian psychology to express their opinions. Then, we have conducted parallel group randomized trials comparing an intervention group with a control group, analyzed the results by an analysis method such as Data Envelopment Analysis (DEA), and verified the effectiveness of the devised method. As a result, the findings have revealed that teams in which the team management was carried out according to the devised method tends to be more effective and prone to excellent effectiveness.

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