scholarly journals Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Candice Downey ◽  
Rebecca Randell ◽  
Julia Brown ◽  
David G Jayne
Keyword(s):  
Pilot Study ◽  
Hospital Stay ◽  
Remote Monitoring ◽  
Continuous Monitoring ◽  
Controlled Trial ◽  
Vital Signs ◽  
Length Of Hospital Stay ◽  
Early Warning Score ◽  
Vital Signs Monitoring ◽  
Cluster Randomized

BACKGROUND Vital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards. OBJECTIVE The aim of this pilot study was to evaluate whether continuous remote vital signs monitoring is a practical and acceptable way of monitoring surgical patients and to optimize the delivery of a definitive trial. METHODS We performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study. Patients admitted to 2 surgical wards at a large tertiary hospital received either continuous and intermittent vital signs monitoring or intermittent monitoring alone using an early warning score system. Continuous monitoring was provided by a wireless patch, worn on the patient’s chest, with data transmitted wirelessly every 2 minutes to a central monitoring station or a mobile device carried by the patient’s nurse. The primary outcome measure was time to administration of antibiotics in sepsis. The secondary outcome measures included the length of hospital stay, 30-day readmission rate, mortality, and patient acceptability. RESULTS Overall, 226 patients were randomized between January and June 2017. Of 226 patients, 140 were randomized to continuous remote monitoring and 86 to intermittent monitoring alone. On average, patients receiving continuous monitoring were administered antibiotics faster after evidence of sepsis (626 minutes, n=22, 95% CI 431.7-820.3 minutes vs 1012.8 minutes, n=12, 95% CI 425.0-1600.6 minutes), had a shorter average length of hospital stay (13.3 days, 95% CI 11.3-15.3 days vs 14.6 days, 95% CI 11.5-17.7 days), and were less likely to require readmission within 30 days of discharge (11.4%, 95% CI 6.16-16.7 vs 20.9%, 95% CI 12.3-29.5). Wide CIs suggest these differences are not statistically significant. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety, despite 24% discontinuing the intervention early. CONCLUSIONS Remote continuous vital signs monitoring on surgical wards is practical and acceptable to patients. Large, well-controlled studies in high-risk populations are required to determine whether the observed trends translate into a significant benefit for continuous over intermittent monitoring. CLINICALTRIAL International Standard Randomised Controlled Trial Number ISRCTN60999823; http://www.isrctn.com /ISRCTN60999823 (Archived by WebCite at http://www.webcitation.org/73ikP6OQz)

scholarly journals Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
C. L. Downey ◽  
J. Croft ◽  
G. Ainsworth ◽  
H. Buckley ◽  
B. Shinkins ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Remote Monitoring ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vital Signs ◽  
Length Of Hospital Stay ◽  
Major Surgery ◽  
Control Group ◽  
Vital Signs Monitoring ◽  
Randomised Controlled

Abstract Background Despite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient’s mobility. The aim of this study was to evaluate the feasibility, acceptability and clinical outcomes of continuous remote monitoring after major surgery. Methods The study was a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery were randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring was achieved using the SensiumVitals® wireless patch which is worn on the patient’s chest and monitors heart rate, respiratory rate and temperature continuously, and alerts the nurse when there is deviation from pre-set physiological norms. Feasibility was assessed by evaluating recruitment rate, adherence to protocol and randomisation and the amount of missing data. Clinical outcomes included time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of hospital readmission within 30 days of discharge. Results One hundred and thirty-six patients were randomised between October 2018 and April 2019: 67 to the control group and 69 to the intervention group. Recruitment was completed prior to the 12 month target with a high rate of eligibility and consent. Missing data was limited only to questionnaire responses; no participants were lost to follow-up and only one participant was withdrawn due to loss of capacity. The number of patients classed as ‘drop-out’ due to design (8.1%) were less than anticipated, and there were no participants who crossed over into the alternative trial allocation group. Seventeen participants in the intervention group (28%) did not adhere to the monitoring protocol. No formal comparisons between arms was undertaken; however, participants had fewer unplanned critical care admissions (1 versus 5) and had a shorter average length of hospital stay (11.6 days (95% confidence interval 9.5–13.7 days) versus 16.2 days (95% confidence interval 11.3–21.2 days)) in the continuous vital signs monitoring group. The time taken to receive antibiotics in cases of sepsis was similar in both arms. A cost-utility analysis indicated that the remote monitoring system was cost-saving when compared to standard NEWS monitoring alone. Conclusions It is feasible to perform a large-scale randomised controlled trial of continuous remote monitoring after major surgery. Progression to a definitive multicentre randomised controlled trial would be appropriate, taking consideration of factors, such as patient adherence, that might mask the potential benefit of additional monitoring. Trial registration ISRCTN registry with study ID ISRCTN16601772. Registered 30 August 2017.

scholarly journals Implementation of enhanced recovery after surgery in gynecological operations: a randomized controlled trial

2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Amr Nady Abdelrazik ◽  
Ahmad Sameer Sanad
Keyword(s):  
Hospital Stay ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Gynecologic Surgery ◽  
Complication Rates ◽  
Control Groups ◽  
Analog Scale ◽  
Randomized Controlled

Abstract Background To investigate the effects of enhanced recovery after surgery (ERAS) in patients undergoing gynecologic surgery on length of hospital stay, pain management, and complication rate. Results The length of hospital stay was reduced in ERAS groups when compared with the control groups (3.46 days vs 2.28 days; P < 0.0001; CI − 1.5767 to − 0.7833 for laparotomy groups and 2.18 vs 1.76 days; P = 0.0115; CI − 0.7439 to − 0.0961 for laparoscopy groups respectively). Intraoperative fluid use was reduced in both ERAS groups compared to the two control groups (934 ± 245 ml and 832 ± 197 ml vs 1747 ± 257 ml and 1459 ± 304 respectively; P < 0.0001) and postoperative fluid use was also less in the ERAS groups compared to the control groups (1606 ± 607 ml and 1210 ± 324 ml vs 2682 ± 396 ml and 1469 ± 315 ml respectively; P < 0.0001). Pain score using visual analog scale (VAS) on postoperative day 0 was 4.8 ± 1.4 and 4.1 ± 1.2 (P = 0.0066) for both laparotomy control and ERAS groups respectively, while in the laparoscopy groups, VAS was 3.8 ± 1.1 and 3.2 ± 0.9 (P = 0.0024) in control and ERAS groups respectively. Conclusion Implementation of ERAS protocols in gynecologic surgery was associated with significant reduction in length of hospital stay, associated with decrease intravenous fluids used and comparable pain control without increase in complication rates.

scholarly journals The role of bovine colostrum on recovery time and length of hospital stay of acute diarrhea in infants and children: a double-blind randomized controlled trial

2016 ◽  
Vol 46 (3) ◽  
pp. 127
Author(s):  
IGN Suwarba ◽  
Sudaryat S ◽  
Hendra S ◽  
IKG Suandi ◽  
Raka Widiana
Keyword(s):  
Hospital Stay ◽  
Acute Diarrhea ◽  
Recovery Time ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Bovine Colostrum ◽  
Mean Difference ◽  
Infants And Children ◽  
Double Blind ◽  
Defecation Frequency

Background WHO standard treatment for acute diarrhea remainsunsatisfying to the parents of acute diarrhea patients, particularlythe need of medical treatment. Bovine colostrum contains immuneand growth factors that is thought able to neutralize some agentscausing acute diarrhea in infants and children.Objective To evaluate the efficacy of bovine colostrum as adju-vant therapy on recovery time and length of hospital stay for acutediarrhea in infants and children.Methods A double-blind randomized controlled trial was conductedon infants and children with acute diarrhea admitted to SanglahHospital. Treatment group received standard therapy with bovinecolostrums and control group received standard therapy plus pla-cebo. The primary outcomes were achievement of recovery timeand length of hospital stay. Recovery time was determined by thenumber of days needed to achieve defecation frequency <3 times/day and needed to achieve normal stool consistency.Results Seventy infants and children were enrolled. The treatmentgroup significantly achieved recovery time earlier than the control groupin regard to the time of achieving defecation frequency to <3 times/day [2.31 (0.76) vs 3.34 (1.45); mean difference of -1.03; P= 0.001; CI95% -1.58;-0.48] and normal stool consistency [2.40 (0.77) vs 3.43(1.48); mean difference of -1.03; P = 0.001; CI 95% -1.59;-0.46]. Lengthof hospital stay was shorter in the treatment group than the controlgroup [2.89 (0.78) vs 3.94 (1.53); mean difference of -1.05; P= 0.001;CI 95% (-1.3;-0.7)]. No significant difference was found in mean ofbody weight recovery in two groups [0.47 (0.16) vs 0.49 (0.20); meandifference of -0.03; P=0.556; CI 95%: -0.11;0.06]. Age, nutritionalstatus, breastfeeding, and diarrhea before admission did not influ-ence the study outcome.Conclusion Bovine colostrums as an adjuvant in standard therapyfor acute diarrhea in infants and children is effective in regard toachieve earlier recovery time and shorter length of hospital stay

Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial

The Lancet ◽  
2011 ◽  
Vol 377 (9782) ◽  
pp. 2023-2030 ◽  
Author(s):  
Sabine CA Meijvis ◽  
Hans Hardeman ◽  
Hilde HF Remmelts ◽  
Rik Heijligenberg ◽  
Ger T Rijkers ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Double Blind Placebo
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