RESUMO
BACKGROUND: Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients' tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. METHODS: A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients' level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. CONCLUSION: This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. TRIAL REGISTRATION: PENFUP phase-2 was Registered in Clinicaltrials.gov ( NCT04604665 ) in October 2020.
RESUMO
BACKGROUND: Even though the importance of preparing patients for a surgical event is recognized, there are still gaps about the benefit of improving functional capacity by walking during the waiting time among patients scheduled for non-cardiac surgery. The aim of this study was to evaluate the impact of pre-surgical walking in-hospital length of stay, early ambulation, and the appearance of complications after surgery among patients scheduled for non-cardiac surgery. METHODS: A two-arm, single- blinded randomized controlled trial was developed from May 2016 to August 2017. Eligible outpatients scheduled for non-cardiac surgery, capable of walking, were randomized (2:1 ratio) to receive a prescription of walking 150 min/week during the whole pre-surgical waiting time (n = 249) or conventional care (n = 119). The primary outcome was the difference in hospital length of stay, and secondary results were time to first ambulation during hospitalization, description of ischemic events during hospitalization and after six months of hospital discharge, and the walking continuation. We performed an intention to treat analysis and compared length of stay between both groups by Kaplan-Meier estimator (log-rank test). RESULTS: There were no significant differences in the length of hospital stay between both groups (log-rank test p = 0.367) and no differences in the first ambulation time during hospitalization (log-rank test p = 0.299). Similar rates of postoperative complications were observed in both groups, but patients in the intervention group continued to practice walking six months after discharge (p < 0.001). CONCLUSION: Our study is the first clinical trial evaluating the impact of walking before non-cardiac surgery in the length of stay, early ambulation, and complications after surgery. Prescription of walking for patients before non-cardiac surgery had no significant effect in reducing the length of stay, and early ambulation. The results become a crucial element for further investigation. TRIAL REGISTRATION: PAMP-Phase2 was registered in ClinicalTrials.gov NCT03213496 on July 11, 2017.
