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PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial.

ABSTRACT: Background:The PROtocolized Care to Reduce HYpotension after Spinal Anaesthesia (ProCRHYSA trial) is an unblinded, randomized, monocentric, prospective, three-arm, parallel-group trial aimed at assessing the role of a controlled volemic repletion in reducing both clinically significant hypotension rate and total amount of fluid administered in patients undergoing spinal anaesthesia. Methods/Design:Aim of the study is assessing the effectiveness of a non-invasive tests to guide a titrated volemic repletion before spinal anesthesia in order to reduce post-spinal hypotension rate. After local ethical committee approval of the study (Comitato Etico Cantonale Ref. N. CE2796), we will randomize patients undergoing elective surgery under spinal anesthesia into two parallel groups: in the first vena cava ultrasound will be used in order to assess adequacy of patients' volemic status and consequently guide the administration of crystalloids boluses; in the second passive legs raising test will be used instead of ultrasound for the same purpose. Discussion:The hypothesis we want to test is that the using of these two experimental methods before spinal anaesthesia, compared to the standard method (empirical fluid administration) can reduce the impact of systemic hypotension through an adequate titrated volemic repletion, avoiding both hypotension and fluid overload. The final purpose is to ensure that spinal anaesthesia is performed in the safest way possible. Conclusions:The study will offer a new insight on the possible role of vena cava ultrasound and passive legs raising test as screening tools to prevent hypotension after spinal anesthesia. These tests were already validated in a critical environment, but to the best of our knowledge this is the first time they are applied to an elective surgical population. Trial registration:The trial was registered on May 2014 on www.clinicalstrial.gov with the number NCT02070276.

SUBMITTER: Ceruti S

PROVIDER: S-EPMC5935868 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial.

Ceruti S S Minotti B B De Vivo S S De Christophoris P P Anselmi L L Saporito A A

Contemporary clinical trials communications 20160629

<h4>Background</h4>The PROtocolized Care to Reduce HYpotension after Spinal Anaesthesia (ProCRHYSA trial) is an unblinded, randomized, monocentric, prospective, three-arm, parallel-group trial aimed at assessing the role of a controlled volemic repletion in reducing both clinically significant hypotension rate and total amount of fluid administered in patients undergoing spinal anaesthesia.<h4>Methods/design</h4>Aim of the study is assessing the effectiveness of a non-invasive tests to guide a t ...[more]

PMID: 29736468

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Project description:Background: Protocolized ventilator weaning (PW) strategies utilizing spontaneous breathing trials (SBTs) result in shorter intubation duration and intensive care unit (ICU) length of stay (LOS). We compared respiratory therapy (RT)-driven PW versus usual care (UC) as it pertains to physiologic respiratory parameters, intubation duration, extubation success/reintubation rates, and ICU LOS. Methods: prospective, multicentric, randomized controlled trial was performed in closed medical and surgical ICUs with 24/7 in-house intensivist coverage at six academic medical centers in a resource-limited setting from October 18, 2007, to May 03, 2014. Extubation readiness was determined by the attending physician (UC) or the respiratory therapist (PW) using predefined criteria and SBT. Physiologic variables, serial blood gas measurements, and weaning indices were assessed including the Rapid Shallow Breathing Index (RSBI), negative inspiratory force (NIF), occlusion pressure (P0.1), and dynamic and static compliance (Cdyn and Cs). Results: total of 5502 patients were randomized (PW 2787; UC 2715), of which 167 patients died without ventilator weaning (PW 90; UC 77) and 645 patients were excluded (PW 365; UC 280). Finally, a total of 4200 patients were analyzed (PW 2075; UC 2125). The PW group displayed improvements in minute ventilation (P < 0.001), Cs and Cdyn(both P < 0.05), P0.1 (P < 0.001), NIF (P < 0.001), and RSBI (P < 0.001). Early re-intubation (≤48 h) rates were lower in the PW group (16.7% vs. 24.8%; P < 0.0001), as were late re-intubation rates (5.2% vs. 25.8%; P < 0.0001). Intubation duration was longer in the PW group (P < 0.001), however, hospital LOS was shorter (P < 0.001). Mortality was unchanged (P = 0.19). Conclusion: PW with RT-driven extubation decisions is safe, effective, and associated with decreased re-intubation (early and late), shorter hospital stays, increased intubation duration (statistically but not clinically significant), and unchanged in-patient mortality.

Project description:OBJECTIVE:s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients. DESIGN:Randomized controlled trial. SETTING:Three tertiary care PICUs in the United States. PATIENTS:Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours. INTERVENTIONS:Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32). MEASUREMENTS AND MAIN RESULTS:Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes. CONCLUSIONS:A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.

Project description:Aims:The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children. Materials and methods:This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups. Results:Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group (p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group (p value = 0.016). Conclusion:The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol. ClinicalTrialsgov identifier:NCT03018977. How to cite this article:Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451-458.

Project description:Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged, thereby leading to increased cost. A recent randomized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility. The mechanism by which coffee stimulates intestinal motility is unknown, but caffeine seems to be the most likely stimulating agent. Thus, the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial, herein referred to as CaCo.Patients scheduled for elective laparoscopic colectomy or upper rectum resection are eligible to participate in this double-blinded, placebo-controlled, randomized trial. Patients fulfilling all inclusion criteria will be allocated after the surgical procedure to one of three treatment arms: 100 mg caffeine, 200 mg caffeine, or placebo (corn starch). Patients will take the capsules containing the study medication three times daily with a meal. The primary endpoint of the study is the time to a solid bowel movement. The study treatment will be stopped after the patient produces a solid bowel movement or has taken ten capsules, whichever occurs first. To determine the colonic passage time, patients will take a capsule with radiopaque markers at breakfast for the first 3 days after surgery. On the fourth day, the location of the markers will be determined with an abdominal X-ray scan. Further secondary objectives are the postoperative morbidity and mortality, well-being, sleeping behavior, and length of hospital stay. The study size was calculated to be 180 patients with an interim analysis occurring after 60 patients.From a previous study investigating coffee, evidence exists that caffeine might have a positive influence on the postoperative bowel activity. This double-blinded, placebo-controlled, randomized trial tries to show that caffeine will shorten the postoperative bowel paralysis and, thus, will improve recovery and shorten the hospital stay after colon surgery.Clinicaltrials.gov NCT02510911 Swiss National Clinical Trials Portal SNCTP000001131.

Project description:IntroductionEffectively preventing or treating spinal-induced maternal hypotension is considered to be the Holy Grail of obstetric anaesthesia. Prophylactic fluid preloading and vasopressors decrease hypotension but may aggravate heart load, induce fetal acidosis or maternal bradycardia. Using low-dose local anaesthetic decreases hypotension but may cause insufficient anaesthesia. Whether there is a height-based dosing algorithm of local anaesthetic in spinal anaesthesia for caesarean section that can provide sufficient anaesthesia with less hypotension without prophylactic fluid preloading and vasopressors is unclear. This study was designed to investigate a height-based dosing algorithm of bupivacaine in spinal anaesthesia for caesarean section.Methods and analysisThis single-centre, double-blinded, prospective, non-inferiority, randomised controlled trial will include 264 parturients (between 18 and 45 years of age) who are scheduled for caesarean section. All participants will not receive prophylactic fluid preloading. The participants will be randomly divided into two groups: the test group or conventional group. For parturients in the test group, 0.5% isobaric bupivacaine (1.15-1.70 mL) will be injected into the subarachnoid space without prophylactic vasopressors. The bupivacaine dose depends on the height of subjects. For parturients in the conventional group, 0.5% bupivacaine (1.8 mL) will be injected into the subarachnoid space along with prophylactic vasopressors. The primary outcome is the incidence of maternal hypotension. The secondary outcomes include the failure rate of spinal anaesthesia, level of sensory block, degree of motor block, other complications in parturients, time of operation, neonatal outcome and quality of anaesthesia.Ethics and disseminationThis study was approved by the Ethics Committee of Shenzhen People's Hospital of Jinan University (Permit No. SZY-00251, chairperson Xiaofang Yu) on 8 February 2018The study results will be disseminated through peer-reviewed journals, professional societies and meetings.Trial registration numberNCT03497364; Pre-results.

Project description:BackgroundDiabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management.ObjectiveTo examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension.MethodsA 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management.ResultsOutcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers.ConclusionThe potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada.Trial registrationClinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).

Project description:BackgroundNorepinephrine infusion decreases hypotension after spinal anesthesia during cesarean section. This study aimed to compare the efficacy of norepinephrine infusion and ephedrine bolus against post-spinal hypotension in parturients.MethodsIn this double-blinded, randomized controlled clinical trial, parturients scheduled for elective cesarean section were randomly allocated to receive norepinephrine infusion (0.05 μg·kg-1·min-1) just before spinal anesthesia continuing for 30 min or ephedrine bolus (0.15 mg/kg) just before spinal anesthesia. A rescue bolus (5 μg norepinephrine for the norepinephrine group, and 5 mg ephedrine for the ephedrine group) was administered whenever hypotension occurred. Our primary outcome was the incidence of hypotension within 30 min of spinal anesthesia administration. Secondary outcomes included maternal and neonatal outcomes 30 min after spinal block, and neonatal cerebral oxygenation 10 min after birth.ResultsIn total, 190 patients were enrolled; of these patients, 177 were included in the final analysis. Fewer patients suffered hypotension in the norepinephrine group than in the ephedrine group (29.5% vs. 44.9%, odds ratio [OR]: 0.51, 95% confidence interval [CI]: 0.28-0.95, P = 0.034). Moreover, the tachycardia frequency was lower in the norepinephrine group than in the ephedrine group (OR: 0.22, 95% CI: 0.11-0.44, P < 0.001), and patients suffered less nausea and vomiting (OR: 0.28, 95% CI: 0.11-0.70, P = 0.004). There was no difference in Apgar scores and umbilical arterial blood gas analysis between the two groups. However, neonatal cerebral regional saturations were significantly higher after birth in the norepinephrine group than in the ephedrine group (mean difference: 2.0%, 95% CI: 0.55%-3.45%, P = 0.008).ConclusionIn patients undergoing elective cesarean section with spinal anesthesia, norepinephrine infusion compared to ephedrine bolus resulted in less hypotension and tachycardia, and exhibited potential neonatal benefits.Trial registrationClinicalTrials.gov, NCT02542748; https://clinicaltrials.gov/ct2/show/record/NCT02542748.

Project description:BackgroundData on the best norepinephrine bolus dose for management of hypotension are limited. The aim of this study was to compare the efficacy and safety of two norepinephrine bolus doses in the rescue management of maternal hypotension during cesarean delivery.MethodsThis randomized, controlled trial included mothers scheduled for cesarean delivery with spinal anesthesia with a prophylactic norepinephrine infusion. Following spinal anaesthesia administration, a participant was considered hypotensive if systolic blood pressure was ≤80% compared to the baseline reading. Participants were allocated to receive either 6 mcg or 10 mcg norepinephrine bolus for the management of hypotensive episodes. The hemodynamic response after administration of norepinephrine bolus was recorded. The episode was considered successfully managed if systolic blood pressure returned to within 80% from the baseline reading within 2 min after norepinephrine bolus administration, and did not drop again within 6 min after the norepinephrine bolus. The primary outcome was the incidence of successful management of the first hypotensive episode. Other outcomes included systolic blood pressure, heart rate, incidence of maternal bradycardia, and reactive hypertension.ResultsOne hundred and ten mothers developed hypotensive episodes and received norepinephrine boluses for management. The number of successfully managed first hypotensive episodes was 50/57 (88%) in the 6 mcg-treated episodes and 45/53 (85%) in the 10 mcg-treated episodes (p = 0.78). Systolic blood pressure was comparable after administration of either bolus dose. Heart rate was lower after administration of 10 mcg bolus compared to 6 mcg bolus, without significant bradycardia requiring atropine administration. The incidence of reactive hypertension was comparable between both groups.ConclusionIn mothers undergoing elective cesarean delivery under prophylactic norepinephrine infusion at 0.05 mcg/kg/min, there was no advantage to the use of 10 mcg norepinephrine bolus over 6 mcg norepinephrine bolus for the rescue management of first hypotensive episode. Neither of the 2 bolus doses reached a 100% success rate. The incidences of bradycardia and reactive hypertension were comparable between both norepinephrine doses.Trial registrationAt clinicaltrial.gov registry system on January 4, 2019 Clinical trial identifier: NCT03792906.

Project description:Because of symptoms, people with lumbar spinal stenosis (LSS) are often inactive, and this sedentary behaviour implies risk for diseases including obesity. Research has identified body mass index as the most powerful predictor of function in LSS. This suggests that function may be improved by targeting weight as a modifiable factor. An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS. The main components of this intervention include pedometer-based physical activity promotion and nutrition education.The Spinal Stenosis Pedometer and Nutrition Lifestyle INTERVENTION (SSPANLI) was developed and piloted with 10 individuals. The protocol for a randomized controlled trail comparing the SSPANLI intervention to usual non-surgical care follows. One hundred six (106) overweight or obese individuals with LSS will be recruited. Baseline and follow-up testing includes dual energy x-ray absorptiometry, blood draw, 3-day food record, 7-day accelerometry, questionnaire, maximal oxygen consumption, neurological exam, balance testing and a Self-Paced Walking Test.During Week 1, the intervention group will receive a pedometer, and a personalized consultation with both a Dietitian and an exercise specialist. For 12 weeks participants will log on to the e-health website to access personal step goals, walking maps, nutrition videos, and motivational quotes. Participants will also have access to in-person Coffee Talk meetings every 3 weeks, and meet with the Dietitian and exercise specialist at week 6. The control group will proceed with usual care for the 12-week period. Follow-up testing will occur at Weeks 13 and 24.This lifestyle intervention has the potential to provide a unique, non-surgical management option for people with LSS. Through decreased fat mass and increased function, we may reduce risk for obesity, chronic diseases of inactivity, and pain. The use of e-health interventions provides an opportunity for patients to become more involved in managing their own health. Behaviour changes including increased physical activity, and improved dietary habits promote overall health and quality of life, and may decrease future health care needs in this population.Clinicaltrials.gov, NCT01902979.

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PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial.

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PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial.

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