Lung Ultrasound-Guided Fluid Management versus Standard Care in Surgical ICU Patients: A Randomised Controlled Trial.
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SUBMITTER: Rusu DM
PROVIDER: S-EPMC8394150 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDespite the evidence for calibrated cardiac monitored devices to determine fluid responsiveness, there is minimal evidence that the use of cardiac output monitor devices leads to an overall change in IV fluid use. We sought to investigate the feasibility of performing a randomised controlled study using calibrated cardiac output monitoring devices in shocked ICU patients and whether the use of these devices led to a difference in total volume of IV fluid administered.MethodsWe performed a single-centre non-blinded randomised controlled study which included patients who met the clinical criteria for shock on admission to ICU. Patients were divided into two groups (cardiac output monitors or standard) by block randomisation. Patients allocated to the cardiac output monitor all received EV1000 with Volume View sets. Daily intravenous fluid administration and cumulative fluid balance was recorded for 3?days. The primary outcome assessed was the difference in daily intravenous fluid administration and cumulative fluid balance at 72?h between the two groups. We also assessed how often the clinicians used the cardiac monitor to guide fluid therapy and the different reasoning for initiating further intravenous fluids.ResultsEighty patients were randomised and 37 received calibrated cardiac output monitors. We found no adverse outcomes in the use of calibrated cardiac output monitoring devices and that was feasible to perform a randomised controlled trial. There was no significant difference between the standard care group vs the cardiac monitoring group for cumulative fluid balance (2503?±?3764?ml vs 2458?±?3560?ml, p =?0.96). There was no significant difference between the groups for daily intravenous fluid administration on days 1, 2 or 3. In the cardiac monitored group, only 43% of the time was the EV1000 output incorporated into the decision to give further intravenous fluids.ConclusionIt is feasible to perform a randomised controlled trial using calibrated cardiac output monitoring devices. In addition, there was no trend to suggest that the use of a cardiac monitors leads to lower IV fluid use in the shocked patient. Further trials will require study designs to optimise the use of a cardiac output monitor to determine the utility of these devices in the shocked patient.Trial registrationANZCTR, ACTRN12618001373268. Registered 15 August 2018-retrospectively registered.
| S-EPMC6329049 | biostudies-literature
Project description:ObjectiveWe aimed to evaluate the hysteroscopic management of first-trimester pregnancy loss compared to surgical evacuation either blind or under ultrasonographic guidance.MethodsThis clinical trial included 315 women with first-trimester pregnancy loss, divided equally into three groups. Group 1 underwent traditional blind surgical evacuation, group 2 underwent ultrasound-guided evacuation, and group 3 underwent hysteroscopic management. All women were assessed for retained products, surgical complications, the need for further management, and pregnancy occurrence after evacuation within 2 years of follow up.ResultsThe rate of presence of conception remnants and the need for further treatment was significantly higher in group 1 compared to groups 2 and 3 (4.8% vs. 0% vs. 0%, P = 0.012). The conception rate within 2 years was significantly lower in group 1 compared to groups 2 and 3 (57.4% vs. 73.2% vs. 82.7%, P = 0.002), and the duration needed to conceive was significantly prolonged in group 1 compared to groups 2 and 3 (9.8 vs. 8.3 vs. 6.9 months, P < 0.001). Interestingly, women who underwent hysteroscopic management needed a significantly shorter time to conceive than those who underwent ultrasound-guided evacuation (6.9 vs. 8.3 months, P = 0.006).ConclusionsHysteroscopic management of first-trimester pregnancy loss was superior to ultrasound-guided surgical evacuation regarding the time interval to conceive. Both techniques were superior to the blind evacuation technique regarding removal of the whole conception remnants, need for further treatment and fertility outcomes. Clinical trial registration: It was first registered at ClinicalTrials.gov on 16/03/2017 with registration number NCT03081104.
| S-EPMC9131545 | biostudies-literature
Project description:BackgroundThe aim of this study was to compare the efficacy of ultrasound guided aspiration of hydrosalpinx fluid at the time of oocyte retrieval with salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET.MethodsOne hundred and sixty patients with ultrasound visible hydrosalpinx were randomized into salpingectomy group and aspiration group using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card.ResultsThe clinical pregnancy rate per started cycle and the implantation rate were non- significantly higher in the salpingectomy group compared with the aspiration group [40% vs. 27.5% (p value = 0.132) and 18.95% vs. 12.82% (p value =0.124), respectively]. In the aspiration group, 34.21% of patients had rapid re-accumulation of the hydrosalpinx fluid (i.e. within first two weeks after embryo transfer). Whereas, the clinical pregnancy rate per transfer cycle and the implantation rate were significantly higher in salpingectomy group compared with the subgroup of patients with rapid re-accumulation of hydrosalpinx fluid [42.67% vs. 19.23% (p value = 0.036) and 18.95% vs. 7.58% (p value = 0.032), respectively], no significant differences were detected between the salpingectomy group and the subgroup of patients with no re-accumulation of hydrosalpinx fluid (42.67% vs. 34% (p value = 0.356) and 18.95% vs. 15.5% (p value = 0.457), respectively).ConclusionThe small sample size could be the cause of failure of detecting significant increase in implantation and pregnancy rates in salpingectomy group compared with aspiration group. Further larger randomized controlled trials are needed to determine whether salpingectomy is more effective than aspiration of hydrosalpinx fluid or not. Moreover, the data presented in this study suggested that rapid re-accumulation of hydrosalpinx fluid is an obstacle against successful implantation and the cause of lower success rate with ultrasound guided aspiration of hydrosalpinx fluid compared with salpingectomy.Trial registrationClinical trials.gov ( NCT02008240 ), registered 8 December 2013.
| S-EPMC4364312 | biostudies-literature
Project description:BackgroundIn routine intensive care unit (ICU) practice, fluids are often administered without a safety limit, which may lead to fluid overload and decreased survival. Recently, B-lines score (BLS) has been validated as a lung ultrasound (LUS) quantification of pulmonary congestion. This suggests that LUS may provide a safety threshold to conduct fluid therapy and to avoid overhydration. However, there is no randomized study to test the utility of LUS in guiding fluid management in ICU patients by using a pre-specified BLS cut-off value as a threshold for fluid removal.MethodsLUS Guided Fluid Management Protocol for the Critically Ill Patient is a prospective, multi-centre, randomized controlled trial. Five hundred ICU patients will be randomly assigned in a 1:1 ratio, to protocolized LUS-based fluid management or usual care. The trial intervention will start on ICU admission and will consist in daily assessment of BLS and triggered evacuation of excessive fluids with loop diuretics (Furosemide) when BLS ≥ 15. If rebalancing volume status with diuretics fails, forced evacuation by ultrafiltration will be used. The main endpoint is death from all causes at 28 days from randomization. The secondary outcomes are presence and time-course evolution of organ dysfunctions, ICU- and hospital length of stay, all-cause mortality at 90 days, and health economics data.DiscussionIf study results will show that LUS guided fluid management protocol improves outcome in ICU patients, it will be the base for other studies to refine this protocol or track those categories of critically ill patients to whom it may bring maximum benefits.Trial registrationClinicalTrials.gov, NCT03393065 . Registered on 8 January 2018.
| S-EPMC6482502 | biostudies-literature
Project description:Background Though ultrasound-guided percutaneous lung needle biopsy (US-PLNB) is a first-line small biopsy method for peripheral lung lesions, quality of cellularity in specimens obtained via US-PLNB is uncertain. This study investigated the accuracy, sensitivity, and cellularity of US-PLNB. It examined the ability of contrast-enhanced ultrasound (CEUS) to improve the effectiveness of US-PLNB. Methods We retrospectively analyzed all data of patients with subpleural lung lesions who underwent US-PLNB. The cellularity of US-PLNB from malignant lesions included the tumor cell number and proportion. The definition of high-quality cellularity (HQC) was concurrently achieving a tumor cell number ≥400 and a proportion ≥20%. The sensitivity, the actual numbers of tumor cell number/proportion, and the rate of HQC were calculated and compared between the CEUS and non-enhanced US groups after propensity score matching (PSM) with subgroup analyses by lesion size (small lesion ≤30 mm and large lesion >30 mm). Results A total of 345 patients undergoing 345 US-PLNBs were evaluated, with 3.7±1.1 of punctures on average. There were 201 malignant and 144 benign lesions with a mean size of 43.8±24.1 mm. Among the 201 malignant lesions, 124 cases underwent CEUS and 77 underwent non-enhanced US. The quantity of tumor cells, the proportion of tumor cells, and the rate of HQC in 201 cases of US-PLNB from malignant lesions were 2,862.1±2,288.0, 44.6%±24.5%, and 82.1% [95% confidence interval (CI): 76.6% to 87.1%], respectively. The quantity of tumor cells, the proportion of tumor cells, and rate of HQC were significantly higher in the CEUS group than that in the non-enhanced US group, both in the analysis of overall malignant lesions and in large malignant lesions (all P<0.05). Conclusions The US-PLNB has high sensitivity and thereby obtains HQC samples for subpleural lung malignant lesions. The CEUS helps improve the rate of HQC and tissue cellularity of lung malignancies.
| S-EPMC9622440 | biostudies-literature
Project description:A fluid challenge can generate an infraclinical interstitial syndrome that may be detected by the appearance of B-lines by lung ultrasound. Our objective was to evaluate the appearance of B-lines as a diagnostic marker of preload unresponsiveness and postoperative complications in the operating theater. We conducted a prospective, bicentric, observational study. Adult patients undergoing abdominal surgery were included. Stroke volume (SV) was determined before and after a fluid challenge with 250 mL crystalloids (Delta-SV) using esophageal Doppler monitoring. Responders were defined by an increase of Delta-SV > 10% after fluid challenge. B-lines were collected at four bilateral predefined zones (right and left anterior and lateral). Delta-B-line was defined as the number of newly appearing B-lines after a fluid challenge. Postoperative pulmonary complications were prospectively recorded according to European guidelines. In total, 197 patients were analyzed. After a first fluid challenge, 67% of patients were responders and 33% were non-responders. Delta-B-line was significantly higher in non-responders than responders [4 (2-7) vs 1 (0-3), p < 0.0001]. Delta-B-line was able to diagnose fluid non-responders with an area under the curve of 0.74 (95% CI 0.67-0.80, p < 0.0001). The best threshold was two B-lines with a sensitivity of 80% and a specificity of 57%. The final Delta-B-line could predict postoperative pulmonary complications with an area under the curve of 0.74 (95% CI 0.67-0.80, p = 0.0004). Delta-B-line of two or more detected in four lung ultrasound zones can be considered to be a marker of preload unresponsiveness after a fluid challenge in abdominal surgery.The objectives and procedures of the study were registered at Clinicaltrials.gov (NCT03502460; Principal investigator: Stéphane BAR, date of registration: April 18, 2018).
| S-EPMC8789825 | biostudies-literature
Project description:BackgroundEndobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an effective technique used to precisely detect enlarged mediastinal lymph nodes. The efficacy of EBUS-TBNA versus standard modalities for the diagnosis of sarcoidosis remains to be elucidated. In this meta-analysis, we compared the efficacies of these methods.MethodsWe searched PubMed, Embase, The Cochrane Library, Wanfang, Cpvip, CNKI, and the bibliographies of the relevant references. We analyzed the data obtained with Revman 5.2 (Nordic Cochrane Center, Copenhagen, Denmark) and Stata 12.0 software (Stata Corporation, College Station, TX, USA). The Mantel-Haenszel method was used to calculate the pooled odds ratio (OR) and 95% confidence intervals (CIs).ResultsSixteen studies with a total of 1823 participants met the inclusion criteria, and data were extracted regarding the diagnostic yield of each approach. The ORs for EBUS-TBNA versus transbronchial lung biopsy (TBLB) for the diagnosis of sarcoidosis ranged from 0.26 to 126.58, and the pooled OR was 5.89 (95% CI, 2.20-15.79, P = 0.0004). These findings indicated that EBUS-TBNA provided a much higher diagnostic yield than TBLB. The pooled OR for EBUS-TBNA + TBLB + endobronchial biopsy (EBB) versus TBNA + TBLB + EBB was 1.54 (95% CI, 0.61-3.93, P = 0.36), implying that there was no significant difference between their diagnostic yields. However, clinical heterogeneity was reflected in the nature of the studies and in the operative variables.ConclusionsThe results of this meta-analysis suggest that EBUS-TBNA + TBLB + EBB could be used for the diagnosis of sarcoidosis, if available. At medical centers without EBUS-TBNA, TBNA + TBLB + EBB could be used instead.
| S-EPMC4931269 | biostudies-literature
Project description:BackgroundFluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesise that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.MethodsThe "effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients" (CONFIDENCE) is a national, multicentre, open-label, randomised controlled trial (RCT) in adult critically ill patients that are expected to be invasively ventilated for at least 24 h. Patients with conditions that preclude a negative fluid balance or LUS examination are excluded. CONFIDENCE will operate in 10 ICUs in the Netherlands and enrol 1000 patients. After hemodynamic stabilisation, patients assigned to the intervention will receive daily LUS with fluid balance recommendations. Subjects in the control arm are deresuscitated at the physician's discretion without the use of LUS. The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; 28-day mortality; 90-day mortality; ICU, in hospital and total length of stay; cumulative fluid balance on days 1-7 after randomisation and on days 1-7 after start of LUS examination; mean serum lactate on days 1-7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.DiscussionThe CONFIDENCE trial is the first RCT comparing the effect of LUS-guided deresuscitation to routine care in invasively ventilated ICU patients. If proven effective, LUS-guided deresuscitation could improve outcomes in some of the most vulnerable and resource-intensive patients in a manner that is non-invasive, easy to perform, and well-implementable.Trial registrationClinicalTrials.gov NCT05188092. Registered since January 12, 2022.
| S-EPMC10038369 | biostudies-literature
Project description:To compare the effectiveness of ultrasound-guided genicular nerve block (GNB) and physical therapy (PT) in patients with chronic knee osteoarthritis. A prospective randomised study with 102 patients (45-70 years) was performed wherein the patients received ultrasound-guided GNB (n = 51) and PT (n = 51) along with a standard home exercise programme. Scores for pain on a Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 6-min walking test (6MWT) were assessed pre-treatment and at 2- and 12-weeks post-treatment. Both groups were comparable for sociodemographic characteristics. VAS scores (in mm) in the ultrasound-guided GNB group at 0, 2 and 12 weeks were 7.01 ± 1.36; 3.71 ± 2.18; 5.08 ± 2.22 (p < 0.001) and 6.64 ± 1.99; 4.35 ± 1.09; 5.25 ± 1.33, (p < 0.001) in the PT group. While the increase in the 6MWT test in the 2nd week was similar for both groups (p = 0.073), the increase in walking distance was greater in the ultrasound-guided GNB group at 12 weeks (p = 0.046). As compared to PT, ultrasound-guided GNB is beneficial in reducing pain and increasing functional and physical capacity, with greater retention of effects on the physical capacity seen at 12 weeks. Trial registration number: ClinicalTrials.gov (NCT04782401).
| S-EPMC8852952 | biostudies-literature
Project description:IntroductionDeep wound infection is a catastrophic complication after hip fracture surgery. However, current understanding of infection rates in this population is limited. Many technologies such as incisional negative-pressure wound therapy (NPWT) show promise in reducing the rate of infection. This trial is a feasibility study looking to establish a value estimated with a greater precision of the rate of deep infection after hip fracture treatment in patients treated with NPWT versus standard dressing following hip fracture surgery.Methods and analysisA randomised controlled trial of 464 patients will be run across multiple centres. It is embedded in the World Hip Trauma Evaluation cohort study. Any patient over the age of 65 years having surgery for hip fracture is eligible unless they are being treated with percutaneous screw fixation. A web-based randomisation sequence will stratify patients by centre. Patients will be allocated to either NPWT or standard care on a 1:1 basis. The primary outcome measure is the Centre for Disease Control definition of deep infection at 30 days. Follow-up at 4 months will also assess deep infection and the core outcome dataset for hip fractures. This includes health-related quality of life (EQ-5D-5L), mobility, mortality and late complications such as further surgery. The primary analysis will be intention to treat.Ethics and disseminationOxford C Research Ethics Committee granted ethical approval on 28/04/2017, 17/SC/0207. The results of this study will be reported in a peer-reviewed publication and inform the design of a future full-scale trial.Trial registration numberISRCTN55305726.
| S-EPMC5898317 | biostudies-literature