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Perioperative Care clinical trials

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NCT ID: NCT04997694 Completed - Hypothermia Clinical Trials

Effect of Preoperative Active Warming and Passive Warming Methods on Perioperative Hypothermia

Start date: June 23, 2021
Phase: N/A
Study type: Interventional

70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery occurs later. Low body temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, exposure of large body surface areas, evaporative heat loss during skin preparation using volatile solutions, large open cavity or abdominal surgery longer operative time and exposure to anesthesia, during surgical intervention excessive blood loss etc. surgical intervention poses a risk for the formation of undesirable hypothermia. Cardiovascular and respiratory system problems that may increase mortality due to hypothermia in surgical patients; may cause a decrease in heart rhythm, cardiac output, blood pressure and oxygen saturation, and an increased risk of cardiac arrest and ischemia. With the development of shivering, oxygen consumption increases and the "thermal comfort" of the patient deteriorates. The length of stay in the postoperative unit and hospital stay are prolonged, causing an increase in costs. Among the rapid recovery protocols, it is recommended to pre-warm the patients in the preoperative period to maintain normothermia. Many complications are prevented by different methods and warming procedures performed in the perioperative period. In our study, it was aimed to compare the effects of active and passive warming on hypothermia, vital signs and warmth comfort in the postoperative period in patients who will undergo open abdominal surgery.

NCT ID: NCT04852406 Recruiting - Perioperative Care Clinical Trials

Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery.

NCT ID: NCT04770259 Completed - Surgery Clinical Trials

Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).

APOPM
Start date: May 30, 2021
Phase: N/A
Study type: Interventional

Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population. The EP have a higher disease burden and mortality when facing surgery and in the postoperative period. Thus, this population frequently has longer hospital stays due to its degree of fragility, surgical complications or decompensation of its underlying pathologies, directly affecting health care systems. An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended, with the consequent which entails a higher cost in health. Current research underestimates the conditions of frailty and dependence in the EP. In addition, it is not routinely evaluated prior to surgery, as well as nutritional, metabolic, cognitive status and / or delirium screening is performed. There are accelerated recovery programs, which relate their interventions to specific pathologies; however, the age of the person is not taken into account. Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects, not including an integrative pre-surgical evaluation. Based on the foregoing, a prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals (private and public). The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay. The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation, in addition to contemplating evaluations of frailty, dependence, cognitive status, screening for delirium, nutritional and metabolic.

NCT ID: NCT04724122 Completed - Perioperative Care Clinical Trials

Perioperative Care in Ethiopia

Start date: September 1, 2020
Phase:
Study type: Observational

A national cross-sectional survey of surgery and anaesthesia at Ethiopian public hospital facilities.

NCT ID: NCT04540315 Completed - Perioperative Care Clinical Trials

Reducing Surgical Readmissions Through Mobile Technology

Start date: October 2, 2020
Phase: N/A
Study type: Interventional

This randomized trial will study the effect of a mobile app that facilitates patient engagement (patients undergoing complex abdominal surgery will track metrics of interest to the surgeon, submit reports on their symptoms/pain/physical function, and upload wound images) on readmission to the hospital. This trial will also assess whether the app can impact surgical complication severity, number of emergency department visits, and readmission costs. 300 participants will be enrolled and can expect to be on study for 6 months.

NCT ID: NCT04485650 Completed - Anxiety Clinical Trials

Effect of Music in Intraoperative Period

Start date: February 24, 2017
Phase: N/A
Study type: Interventional

Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status. Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.

NCT ID: NCT04037787 Completed - Colorectal Cancer Clinical Trials

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery

ERAS-Colon
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.

NCT ID: NCT03865810 Not yet recruiting - Gastric Cancer Clinical Trials

Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Gastric Surgery for Cancer

POWER4
Start date: October 22, 2019
Phase:
Study type: Observational

Methods National audit of a 90-day prospective observational cohort in which postoperative complications will be analyzed at 30 days of follow-up in adult patients undergoing scheduled surgery for gastric resection for cancer with or without an intensified recovery program (ERAS : Enhanced Recovery after Surgery) with any level of protocol compliance (from 0-100%) Research Locations Spanish Hospitals at the state level where these surgical interventions are performed on a regular basis. Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality. Sample Size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 28%, the sample size calculation yields 861 patients, although the final sample size it may be smaller depending on the proportion of complications detected. Inclusion criteria Patients older than 18 years who are going to undergo surgery for gastric resection surgery due to cancer regardless of their affiliation to an ERAS intensified recovery program and the compliance level of the protocol (0-100%) Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.

NCT ID: NCT03864861 Not yet recruiting - Clinical trials for Postoperative Complications

Postoperative Outcomes Within an Enhanced Recovery After Bariatric Surgery Protocol

POWER3
Start date: October 22, 2019
Phase:
Study type: Observational

Methods National audit of a 90-day prospective observational cohort in which pre-defined postoperative complications were analyzed at 30 days of follow-up in adult patients undergoing elective bariatric surgery with or without an intensified recovery program (ERAS: Enhanced Recovery after Surgery) with any level of protocol compliance (0-100%) Research Places Spanish Hospitals where this surgical intervention is carried out. Objectives To determine the incidence of postoperative complications per patient and procedure, regardless of the degree of adherence to ERAS protocols and its impact on the hospital stay and postoperative complications including 30-day mortality. Sample size For an alpha error of 5% (95% confidence) and an accuracy of 3% and estimating a number of patients with complications of 11%, the sample size calculation yields 460 patients, although the final sample size it may be smaller depending on the proportion of complications detected. Inclusion criteria Patients older than 18 years who are going to be electively operated on for bariatric surgery regardless of their adherence to an ERAS intensified recovery program and the compliance level of the protocol (from 0-100%) Statistical analysis Continuous variables will be described as mean and standard deviation, if it is a normal distribution, or median and interquartile range, if they are not normally distributed. Comparisons of continuous variables will be performed by one-way ANOVA or the Mann-Whitney test, as appropriate. A univariate analysis will be performed to test the factors associated with postoperative complications, hospital stay and death in the hospital. Univariate analyzes and hierarchical multivariate logistic regression models will be constructed to identify factors associated independently with these results and to adjust for differences in confounding factors. The factors will be introduced in the models based on their relationship with the univariate result (p <0.05), the biological plausibility and the low rate of missing data.

NCT ID: NCT03814681 Not yet recruiting - Clinical trials for Postoperative Complications

Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)

EuroPOWER
Start date: September 15, 2019
Phase:
Study type: Observational

Methods 30 days European Multicentre observational cohort study of postoperative complications following elective colorectal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 30-day cohort period with a planned overnight stay. Research sites Hospitals across Europe with an elective colorrectal surgical service Objective To provide detailed data describing post-operative complications and associated mortality To provide detailed data describing adherence to ERAS protocol and its association to morbidity and length of stay. To provide detailed information on the influence of the volume of patients undergoing surgery on each center and postoperative complications censured at 30 days after surgery. Inclusion criteria All adult patients (aged ≥18 years) undergoing elective colorectal surgery during the 30-day study period. Statistical analysis Number of patients: All eligible patients undergoing elective colorectal surgery during the study month in European participating hospitals. Univariate analysis will be used to test factors (patient, surgical, and ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital death. Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A stepwise approach will be used to enter new terms. A single final analysis is planned at the end of the study. Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose- response dependence in percentage of patients with postoperative complications and LOS.