Driving pressure during general anesthesia for open abdominal surgery (DESIGNATION) : study protocol of a randomized clinical trial

Background Intraoperative driving pressure (Delta P) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (V-T) is kept constant, Delta P may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. Delta P may decrease if PEEP leads to a recruitment of collapsed lung tissue but will increase if PEEP mainly causes pulmonary overdistension. This study tests the hypothesis that individualized high PEEP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery. Methods The "Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial" (DESIGNATION) is an international, multicenter, two-group, double-blind randomized clinical superiority trial. A total of 1468 patients will be randomly assigned to one of the two intraoperative ventilation strategies. Investigators screen patients aged >= 18 years and with a body mass index <= 40 kg/m(2), scheduled for open abdominal surgery and at risk for PPC. Patients either receive an intraoperative ventilation strategy with individualized high PEEP with recruitment maneuvers (RM) ("individualized high PEEP") or one in which PEEP of 5 cm H2O without RM is used ("low PEEP"). In the "individualized high PEEP" group, PEEP is set at the level at which Delta P is lowest. In both groups of the trial, V-T is kept at 8 mL/kg predicted body weight. The primary endpoint is the occurrence of PPC, recorded as a collapsed composite of adverse pulmonary events. Discussion DESIGNATION will be the first randomized clinical trial that is adequately powered to compare the effects of individualized high PEEP with RM versus fixed low PEEP without RM on the occurrence of PPC after open abdominal surgery. The results of DESIGNATION will support anesthesiologists in their decisions regarding PEEP settings during open abdominal surgery

Older patients' experiences with a shared decision-making process on choosing dialysis or conservative care for advanced chronic kidney disease: a survey study

Background: Many older patients approaching end-stage kidney disease have to decide whether to go for dialysis or non-dialytic conservative care (CC). Shared decision-making is recommended to align the treatment plan with the patient's preferences and values. Little is known about older patients' experiences with shared decision-making on dialysis or CC. Methods: We performed a survey study, in collaboration with the Dutch Kidney Patients Association, in 99 patients aged ≥70 years who had chosen dialysis (n = 75) or CC (n = 24) after a shared decision-making process involving an experienced multidisciplinary team. Results: Patients stated to be overall satisfied with the shared decision-making process (% with score 6-10 on 11-point Likert scale, dialysis versus CC: 93% vs. 91%, P = 0.06), and treatment decision (87% vs. 91%, P = 0.03). However, patients also reported negative experiences, especially those who had chosen dialysis. Such negative experiences were related to the timing, informing, and level of decision-making being shared. More patients who selected dialysis indicated to have felt forced to make a decision, mostly due to the circumstances, such as their deteriorating health or kidney function, or by their nephrologist (31% vs. 5%, P = 0.01). Also, patients who selected dialysis mentioned a perceived lack of choice as most common reason for choosing dialysis, and 55% considered their own opinion as most important rather than their nephrologists' or relatives' opinion compared to 90% of the patients who had chosen CC (P = 0.02). A subset of patients who had chosen dialysis still doubted their treatment decision compared to no patient who had chosen CC (17% vs. 0%, P = 0.03). Conclusions: Older patients reported contrasting experiences with shared decision-making on dialysis or CC. Despite high overall satisfaction, the underlying negative experiences illustrate important but modifiable barriers to an optimal shared decision-making process

Differences in mental health status during the COVID-19 pandemic between patients undergoing in-center hemodialysis and peritoneal dialysis

BACKGROUND: The mental health of dialysis patients during the COVID-19 pandemic may have been modulated by dialysis modality. Studies comparing mental health of in-center hemodialysis and peritoneal dialysis patients during the first 2 years of the pandemic are lacking. METHODS: We conducted repeated cross-sectional and multivariable regression analyses to compare the mental health of in-center hemodialysis and peritoneal dialysis patients from March 2019 until August 2021 using data from the Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes. The study period was divided into one pre-pandemic and six 3-month pandemic periods (period 1-period 6). Mental health was assessed with the Mental Component Summary score of the 12-item Short Form health survey and mental symptoms of the Dialysis Symptom Index. RESULTS: We included 1274 patients (968 on in-center hemodialysis and 306 on peritoneal dialysis). Mental Component Summary scores did not differ between in-center hemodialysis and peritoneal dialysis patients. In contrast, in-center hemodialysis patients more often reported nervousness during period 3 (27% vs 15%, P?=?0.04), irritability and anxiety during period 3 (31% vs 18%, P?=?0.03, 26% vs. 9%, P?=?0.002, respectively) and period 4 (34% vs 22%, P?=?0.04, 22% vs 11%, P?=?0.03, respectively), and sadness in period 4 (38% vs 26%, P?=?0.04) and period 5 (37% vs 22%, P?=?0.009). Dialysis modality was independently associated with mental symptoms. CONCLUSIONS: In-center hemodialysis patients more often experienced mental symptoms compared to peritoneal dialysis patients from September 2020 to June 2021, which corresponds to the second lockdown of the COVID-19 pandemic. Mental health-related quality-of-life did not differ between in-center hemodialysis and peritoneal dialysis patients. TRIAL REGISTRATION NUMBER: Netherlands Trial Register NL6519, date of registration: 22 August, 2017