Enrollment in clinical trials may be associated with improved outcomes compared with standard care, but results are heterogeneous. The extent to which eligiblenot-enrolled patients impact study generalizability is not well documented in the critical care setting. What This Study Adds to the FieldEnrollment in trials of mechanical ventilation may be associated with improved outcomes compared with standard care outside of a trial. There is a need for prospective tracking and transparent reporting of eligible-not-enrolled patients as part of trial management This article has an online data supplement, which is accessible from this issue's table of content online at www.atsjournals.org 3 ABSTRACT Rationale: Patients eligible for randomized controlled trials (RCTs) may not be enrolled for various reasons. Non-enrollment may affect study generalizability and lengthen the time required for trial completion.Objectives: We sought to describe characteristics and outcomes of eligible nonenrolled (ENE) patients in a multicenter trial of mechanical ventilation strategies. Methods:Within the OSCILLATE trial of high-frequency oscillation (HFO) versus conventional ventilation (CV) in adults with ARDS, and with approval from research ethics boards, we collected a minimal dataset on patients who satisfied eligibility criteria but were not enrolled. We categorized ENE patients as ENE-HFO and ENE-CV based on receipt of HFO at any time. We used multivariable logistic regression to assess the association between ENE status and mortality.Measurements and Main Results: 548 patients were randomized, and 546 were ENE. The most common reasons for ENE were no consent (42%), physician refusal (24%), missed randomization window (15%), and current HFO use (14%). Compared with randomized patients in respective arms of the trial, ENE-HFO patients were younger and had worse lung injury while ENE-CV patients had lower illness severity. ENE status was independently associated with mortality (adjusted OR 1.39, 95%CI 1.06-1.84; p=0.02); with no significant interaction with ventilation treatment group.Conclusions: Non-enrollment was common, with approximately 1 ENE patient for every randomized patient. Our study suggests that enrollment in trials of mechanical ventilation may be associated with improved outcomes compared with standard care and highlights the need for prospective tracking and transparent reporting of ENE patients as part of trial management.4
SummaryIn order to lower departmental costs in an ophthalmological outpatient department by reducing wastage, the stability of available chlorine at levels of 280 ppm and 560 ppm in litre solutions of sodium dichloroisocyanurate was investigated over a three-week period. There was no significant decay in available chlorine at these levels in solutions kept at 20°C. Sodium dichloroisocyanurate may be prepared on a weekly instead of a daily basis with an annual saving of £1200 to £1400.
Introduction Risks of endotracheal tube cuff (ETTC) over inflation must be balanced with the need to achieve a minimum pressure of 20 cm H2O. Methods have been developed to estimate adequate ETTC pressurization but do not provide accurate endotracheal tube cuff pressure (ETCP) measurements. Hence, different sized syringes may play a role in determining ETCP. Objectives Determine optimal syringe size for recommended ETCP. Methods Two hundred patients were randomized to use of either a 10‐mL syringe (standard syringe) or a 5‐mL syringe (study group) for ETTC inflation. Following the insertion of the endotracheal tube, the ETTC was inflated per the attending anesthesiologist. Within 10 minutes of intubation, ETCP was measured with a hospital‐provided manometer. Results The percentage of in range cuff pressures for the 5‐mL group was 10.53% and 6.78% for the 10‐mL group. 84.21% (n = 64) of the study group and 91.53% (n = 54) of the control group had cuff pressures exceeding 30 cmH2O. Although our study did not demonstrate that syringe size was predictive of ideal cuff pressure ranges, the average cuff pressure for the 5‐mL group was 55.8 cm H2O versus 68.8 cm H2O in the 10‐mL group. Conclusion Although both 5‐ and 10‐mL syringes resulted in elevated cuff pressures after intubation, 5‐mL syringes resulted in a lower degree of elevation. Use of a 5‐mL syringe should be considered when inflating the endotracheal cuff to possibly reduce patient harm secondary to elevated cuff pressures. Further studies assessing smaller syringe sizes to reduce cuff pressures are warranted.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.