IntroductionTrauma accounts for nearly 10% of the global burden of disease. Several trauma life support programmes aim to improve trauma outcomes. There is no evidence from controlled trials to show the effect of these programmes on patient outcomes. We describe the protocol of a pilot study that aims to assess the feasibility of conducting a cluster randomised controlled trial comparing advanced trauma life support (ATLS) and primary trauma care (PTC) with standard care.Methods and analysisWe will pilot a pragmatic three-armed parallel, cluster randomised controlled trial in India, where neither of these programmes are routinely taught. We will recruit tertiary hospitals and include trauma patients and residents managing these patients. Two hospitals will be randomised to ATLS, two to PTC and two to standard care. The primary outcome will be all-cause mortality at 30 days from the time of arrival to the emergency department. Our secondary outcomes will include patient, provider and process measures. All outcomes except time-to-event outcomes will be measured both as final values as well as change from baseline. We will compare outcomes in three combinations of trial arms: ATLS versus PTC, ATLS versus standard care and PTC versus standard care using absolute and relative differences along with associated CIs. We will conduct subgroup analyses across the clinical subgroups men, women, blunt multisystem trauma, penetrating trauma, shock, severe traumatic brain injury and elderly. In parallel to the pilot study, we will conduct community consultations to inform the planning of the full-scale trial.Ethics and disseminationWe will apply for ethics approvals to the local institutional review board in each hospital. The protocol will be published to Clinical Trials Registry—India and ClinicalTrials.gov. The results will be published and the anonymised data and code for analysis will be released publicly.
<p class="abstract"><strong>Background:</strong> Intravenous catheters cause endothelial damage and trauma, which can predispose to venous thrombosis. Peripheral vein infusion thrombophlebitis occurs in 25- 35% of hospitalized patients with intravenous catheters and has both patient-related implications (e.g., sepsis) and economic consequences (e.g., extra nursing time). This study is designed to address this issue, by assessing the potential risk factors in those who have developed phlebitis, and deriving conclusions based on the same.</p><p class="abstract"><strong>Methods:</strong> A total of 830 patients were observed over a period of 2 months. All details of the patient were collected. Thrombophlebitis was graded using Visual Infusion Phlebitis Score. Each case was compared with a matching control. </p><p class="abstract"><strong>Results:</strong> 53 of 830 patients observed, developed thrombophlebitis giving an incidence of 6.4%. 92.5% had IV cannulation flushed after insertion. IV cannula had to be changed at least 2 times during the hospital stay. All had an average IV cannulation for 5 days. All had insertion of same size cannula (20G). Level 1 Phlebitis was identified in 64.15% patients, level 2 Phlebitis in 33.96% patients and Level 3 Phlebitis was seen 1.88% patients.</p><p class="abstract"><strong>Conclusions:</strong> Significant association was noted between the number of times the catheter was changed since admission and administration of Potassium chloride and Certain Medications such as Piperacillin through the cannula.</p>
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