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NCT ID: NCT03188770 Not yet recruiting - Clinical trials for Mechanical Ventilation

Practice of Ventilation in Middle-Income Countries

PRoVENT-iMIC
Start date: October 2017
Phase: N/A
Study type: Observational

The purpose of this international, multicenter service review is to describe and compare ventilation management in patients at risk of acute respiratory distress syndrome (ARDS) versus patients not at risk and patients with established ARDS, and to ascertain whether certain ventilator settings and ventilation parameters are associated with pulmonary complications or development of ARDS after start of ventilation in patients in intensive care units (ICUs) in Asian countries. Participating centers will include adult patients undergoing mechanical ventilation in the ICU during a 28-day period. Patients' data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy, duration of ventilation, length of ICU stay and ICU mortality.

NCT ID: NCT03111784 Completed - Fish Consumers Clinical Trials

Effect of Fish Consumption on Cardiovascular Risk Factors

Start date: December 1, 2015
Phase: N/A
Study type: Interventional

IConsumption of fish provides a vital contribution to the survival and health of a significant portion of the world's population. Lipids in fish foods consist mainly of long-chain polyunsaturated fatty acids (PUFAs) such as eicosapentaenic acid (EPA, C20:5n-3) and docosahexaenoic acid (DHA C22:6n-3) which belongs to the physiologically important group of n-3 fatty acids. The increase of unsaturated fatty acids, along with the reduction of saturated fats, supports the lowering of blood cholesterol in humans and causes a positive impact on human nutrition. Polyunsaturated fatty acids (omega-3 fatty acids) plays a role in preventing heart disease and has anti-inflammatory and anti-thrombosis effects and these fatty acids cannot be synthesized and they must be obtained through diet. These nutritional benefits of fish consumption is mainly attributed to the effect of omega-3 polyunsaturated fatty acids , which are thought to have several potential cardio protective actions. This research is focused mainly identify highly consumed food fishes available in Batticaloa district( fresh, lagoon and sea water ) and their consumption pattern (cooking methods) of local community and by cardiovascular patients (CV) . Secondly Omega-3- Polyunsaturated fatty acid (PUFA) and tocopherol content (Vit E) in the fresh fish and dried or smoked fish of the highly consumed food fishes would be assessed and the relationship between fish consumption and its PUFA and Vit E content would be known. Also research will focus how lifestyle, socio-demographic factors' influences on the Cardiovascular diseases among community.

NCT ID: NCT02893280 Withdrawn - Clinical trials for Acute Coronary Syndrome

Acute Coronary Syndrome Sri Lanka Audit Project

ACSSLAP
Start date: April 2015
Phase: N/A
Study type: Observational

ACSSLAP is the first island wide audit project in Sri Lanka on ACS.

NCT ID: NCT02747927 Active, not recruiting - Healthy Volunteers Clinical Trials

Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

TIDES
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.

NCT ID: NCT02718222 Recruiting - Contraception Clinical Trials

Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

Start date: September 2015
Phase: N/A
Study type: Interventional

Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.

NCT ID: NCT02570152 Active, not recruiting - Dengue Clinical Trials

A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

Start date: May 7, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

NCT ID: NCT02523456 Completed - Cardiac Arrest Clinical Trials

Develop, Implement and Assess Effectiveness of Early Warning Score (EWS) for Moneragala District General Hospital

EWS
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

Rationale: Early detection and timely interventions are important determinants of clinical outcome in people with acute illness. Adverse outcomes including unplanned transfer to intensive care (ICU), cardiac arrest and death are usually preceded by acute physiological changes manifesting as alterations in vital signs. Usage of early warning scores (EWS) based on bedside vital sign observations may help early detection, improve outcome of patients and reduce healthcare cost. EWS which are effective in predicting deteriorating patients developed in high income countries have been shown to lose sensitivity and specificity when applied to a low income setting. It is imperative to explore the usefulness of EWSs in Sri Lanka. If the results are positive, widespread adaptation of these scores can significantly contribute to improved patient outcome, better utilization of ICU services and cost effective healthcare provision. Objectives: To describe the demographic characteristics of cardiac arrest patients and the availability of physiological variables for calculation various EWSs in DGH, Moneragala To validate an early warning score suitable for patients at DGH, Moneragala To examine the effectiveness of the selected EWS at improving pre-defined patient outcomes Proposed methodology: Study I: All clinical variables and patient characteristics of past two years collected retrospectively from BHTs. Vital signs and laboratory measurements 24 and 48 hours before cardio respiratory emergency and at admission to hospital will be extracted. The availability of variables required for the calculation of various EWSs will be noted. Study II: All consecutive inpatient admissions for three months to all units except intensive care unit at DGH, Moneragala will be included to the study, prospectively. Data will be collected from bed head tickets using pre-defined data sheets by nominated medical/ nursing officers daily. Demographic details and physiological data will be recorded on admission to ward. Physiological data for seven EWS will be collected twice daily by these medical/nursing officers. Study III: Training will be given for the staff to identify patients getting worse using the newly validated EWS. The outcome of this will be measured with information obtained from Study II. Ethical clearance obtained from the Ethics review Committee of the Faculty of Medicine, University of Colombo (EC-15-034).

NCT ID: NCT02495441 Recruiting - Clinical trials for Premature Rupture of Membranes

Rapid Immunoassay Tests for the Detection of Ruptured Membranes

Start date: August 2015
Phase: N/A
Study type: Observational

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

NCT ID: NCT02387385 Recruiting - Clinical trials for Neonatal Encephalopathy

Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

HELIX
Start date: August 2015
Phase: N/A
Study type: Interventional

Neonatal Encephalopathy is a serious condition arising from unexpected lack of cerebral blood flow and oxygen supply to the foetal brain at the time of birth. Every year, approximately one million babies die from neonatal encephalopathy in low and middle-income countries and a quarter of these deaths occur in India. In the past decade, a number of clinical trials in high-income countries has shown that cooling therapy along with optimal neonatal intensive care reduces death and neurodisability after neonatal encephalopathy. Cooling therapy is now used as a standard therapy after neonatal encephalopathy in all high income countries, including the UK. Although the burden of neonatal encephalopathy is far higher in low and middle-income countries, the safety and efficacy data on cooling therapy from high income cooling trials cannot be extrapolated to these settings, due to the difference in population co-morbidities and sub-optimal neonatal intensive care. The HELIX trial proposes to examine whether whole body cooling to 33.5°C initiated within 6 hours of birth and continued for 72 hours reduces death or neurodisability at 18 months after neonatal encephalopathy in public sector neonatal units in India. A total of 408 babies with moderate or severe neonatal encephalopathy will be recruited from the participating centres in India over an 18 to 24 month period. The babies will be randomly allocated to whole body cooling or usual care. The cooling therapy will be achieved using an approved cooling device (Tecotherm) that is already in clinical use in the UK and in India. MR imaging and spectroscopy will be performed at 1 week of age to examine the brain injury. Neurodevelopmental outcomes will be assessed at 18 months of age. Primary outcome measure is death or moderate/severe neurodisability at 18 months.

NCT ID: NCT02368392 Completed - Clinical trials for In-hospital Cardiac Arrest

National Cardiac Arrest Survey

NCAS
Start date: July 2014
Phase: N/A
Study type: Observational

The aim of this study is to describe incidence of "in-hospital" deaths and outcomes after attempted cardiac arrest resuscitation, availability of resuscitation equipment and medical staff training in state Hospitals of Sri Lanka.