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Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial.

ABSTRACT: Photoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.The hemodynamic optimization using photoplethysmography (PANEX3) trial is a monocentric, randomized, single-blind, controlled, two parallel arm, superiority trial, randomizing 160 patients with an intermediate risk of postoperative complications after colorectal surgery. Informed consent will be obtained from all participants. The hemodynamic optimization is conducted using a specified hemodynamic algorithm either with photoplethysmography (the photoplethysmography group) or with conventional mean arterial pressure (the control group). The anesthesiologist performed a 1:1 randomization the day before surgery using a scratch card, which is available 24/7. The randomization sequence is generated using permutated blocks. Both the patients and surgeons are blinded to the allocation group. The primary outcome is the incidence of at least one postoperative complication during the 30 days following surgery. Two independent experts, who were blinded to the group allocations, validate the complication for each patient using an a priori classification. The secondary outcomes are to study the total number of postoperative complications, the real length of hospital stays, and the postoperative mortality between each group.The PANEX3 trial is the first randomized controlled study conducted to investigate whether perioperative hemodynamic optimization using photoplethysmography during colorectal surgery could decrease the incidence of patients having at least one postoperative complication.ClinicalTrials.gov Identifier: NCT02343601.

SUBMITTER: Fischer MO

PROVIDER: S-EPMC4804484 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial.

Fischer Marc-Olivier MO Fiant Anne-Lise AL Boutros Mariam M Flais Frédéric F Filipov Tzetan T Debroczi Stéphane S Pasqualini Léa L Rhanem Toufiq T Gérard Jean-Louis JL Guittet Lydia L Hanouz Jean-Luc JL Alves Arnaud A Parienti Jean-Jacques JJ

Trials 20160322

<h4>Background</h4>Photoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.<h4>Methods/design</h4 ...[more]

PMID: 27004412

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Project description:BACKGROUND:Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients' postoperative quality of life, as well as health care costs. METHODS/DESIGN:This is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months. DISCUSSION:This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality. TRIAL REGISTRATION:Trial registration: NCT03021525 . Registered on 12 January 2017.

Project description:BACKGROUND:Postoperative morbidity following gastrointestinal tract major surgery ranges between 40% and 60%. Malnutrition, poor protein intake, and surgery-related impairment of the immune system and its function have been associated with postoperative infections. Supplemental perioperative nutrition may improve nutrition by increasing protein intake to influence cell-mediated immunity, thereby reducing the rate of postoperative infectious complications. OBJECTIVE:The primary objective of our trial is to determine the proportion of eligible patients randomized in an 18-month period. The primary feasibility outcome will be to (1) stop, main study not feasible: estimated proportion of randomized patients <40.0% (40/100); (2) continue with protocol modifications: estimated proportion of randomized patients 40.0% (40/100) to 59.0% (50/100); or (3) continue without modification: estimated proportion of randomized patients ?60.0% (60/100). The secondary objectives are to evaluate compliance with the nutritional supplements and to estimate differences in postoperative complications, global health-related quality of life (QoL), and median length of hospital stay between the groups. METHODS:This is a double-blind randomized placebo-controlled feasibility trial. The intervention comprises three nutritional supplements: a protein isolate powder (ISOlution); immunomodulation (INergy-FLD), formulated liquid diet; and carbohydrate loading (PreCovery). Patients will consume 1 serving of the protein supplement per day from the randomization time up to 6 days before surgery (30 days in total). The immunomodulation, a solution that contains arginine, protein isolate, omega-6 fatty acids, and RNA, aims to attenuate excessive inflammatory responses and to replenish nutrients. This solution will be consumed as 3 doses per day for 5 days before and after surgery. Carbohydrate loading helps to reduce the stress from surgery by decreasing insulin resistance. Patients will have 2 servings the evening before surgery and 1 serving 2-3 hours before surgery. To be eligible, patients must have a resectable gastrointestinal cancer for which an elective operation is planned. Patients will be stratified according to nutritional status. The operation should occur within 4 weeks from enrollment. RESULTS:We expect to screen 165 eligible patients; 60.6% (100/165) of them will be randomized to either intervention or placebo. Assuming a two-sided alpha of .05, this will give us a 95% CI around the estimate of 53%-68%. A sample size of 50 per group will enable us to estimate the treatment effect and corresponding variance of the complication rate and QoL measures with adequate precision. The success is defined as the proportion of eligible patients randomized as ?60.0% (60/100). Patients' compliance is defined as an intake of at least 70% (41/58) sachets of the intervention volume. CONCLUSIONS:The results will help to determine the feasibility of a larger randomized controlled trial to implement a perioperative nutritional supplement program for patients undergoing gastrointestinal surgery for cancer. TRIAL REGISTRATION:ClinicalTrials.gov NCT03445260; https://clinicaltrials.gov/ct2/show/NCT03445260 (Archived by WebCite at http://www.webcitation.org/72CAmMzgP). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/10491.

Project description:BackgroundThe medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics.MethodsWe developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24?h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status.DiscussionWe describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis.Trial registrationThe protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783 ) on November 25, 2019, retrospectively registered.

Project description:Enhanced recovery after surgery (ERAS) programs are aimed at minimizing postoperative stress and accelerating postoperative recovery by implementing multiple perioperative principles. "Early mobilization" is one such principle, but the quality of assessment and monitoring is poor, and evidence of improved outcome is lacking. Activity trackers allow precise monitoring and automatic feedback to the patients to enhance their motivation for early mobilization. The aim of the study is to monitor and increase the postoperative mobilization of patients by giving them continuous automatic feedback in the form of a step count using activity-tracking wristbands.Patients undergoing elective open and laparoscopic surgery of the colon, rectum, stomach, pancreas, and liver for any indication will be included. Further inclusion criteria are age between 18 and 75 years, American Society of Anesthesiologists Physical Status class less than IV, and a signed informed consent form. Patients will be stratified into two subgroups, laparoscopic and open surgery, and will be randomized 1:1 for automatic feedback of their step count using an activity tracker wristband. The control group will have no automatic feedback. The sample size (n = 30 patients in each of the four groups, overall n = 120) is calculated on the basis of an assumed difference in step count of 250 steps daily (intervention group versus control group). The primary study endpoint is the average step count during the first 5 postoperative days; secondary endpoints are the percentage of patients in the two groups who master the predefined mobilization (step count) targets, assessment of additional activity data obtained from the devices, assessment of preoperative mobility, length of hospital and intensive care unit stays, number of patients who receive physiotherapy, 30-day mortality, and overall 30-day morbidity.Early mobilization is a key element of ERAS. However, enhanced early mobilization is difficult to define, to assess objectively, and to implement in clinical practice. Consequently, there is a discrepancy between ERAS targets and actual practice, especially in patients undergoing major visceral surgery. This study is the first randomized controlled trial investigating the use and feasibility of activity tracking to monitor and enhance postoperative early mobilization.ClinicalTrials.gov identifier: NCT02834338 . Registered on 15 June 2016.

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Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial.

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Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial.

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