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Intensive Care clinical trials

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NCT ID: NCT06316986 Not yet recruiting - Nutrition Clinical Trials

Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care.

NGPOD
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks. Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies. Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree. Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel. An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned). Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.

NCT ID: NCT06110390 Recruiting - Critical Care Clinical Trials

High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients

Start date: October 17, 2020
Phase: N/A
Study type: Interventional

A significant proportion of patients who are intubated for trauma-related injuries, will fail the extubation process. This means that, when the decision has been made to remove the endotracheal tube, a certain proportion of these patients will require the endotracheal tube to be re-inserted. Global estimates for the rates of re-intubation range from 5-15% of all patients who have had attempted extubation on Intensive Care Units. The exact figures for intubated victims of trauma are not available. Re-intubation is associated with increased intensive care and hospital length of stay, increased morbidity, and the physical risks to the patient inherent with the intubation process. There is also some evidence that the rates of tracheostomy are higher in patients who have failed extubation. A number of interventions have been developed to help prevent extubation failure. Non-invasive ventilation and high-flow nasal oxygen are routinely employed in practice. However, there have been no specific studies of these interventions in TICU patients. High-flow nasal oxygen therapy (HFNO) has emerged over the last decade as a viable adjunct in the management of patients suffering from, or at risk of, hypoxemic respiratory failure. Within the intensive care unit settings, HFNO has been studies in terms of preventing intubation, but it has been evaluated more often in terms of preventing extubation failure. Our study aims to answer the question of whether HFNO is effective at preventing extubation failure in intubated and ventilated victims of traumatic injuries. Previous studies on the same subject, are not based on unequivocal, robust RCTs with low risk of bias. Our primary outcome measure is re-intubation rates and secondary outcome measures are CO2 accumulation rates, atelectasis rates, nutrition status within first 24 hours post extubation, and post - extubation rates of vomiting. Ours will be a prospective, randomized clinical control study. There will be three arms to the study: a control arm, and two intervention arms. Randomization will be done on a permuted block basis. The control arm will be patients receiving standard oxygen therapy, and the intervention arms will be either High Flow Nasal Oxygen Therapy or Non-invasive Ventilation via mask. We propose that, when compared with either face-mask O2, NIV (CPAP), HFNO administered continuously for 24 hours post extubation of trauma patients on ICU, will result in better patient-related outcomes.

NCT ID: NCT06049758 Not yet recruiting - Blood Loss Clinical Trials

D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

Evaluating the differences between D2 and D3 lymphadenectomy in laparoscopic right hemicolectomy in patients with right cancer colon post-operative outcome, intra-operative blood transfusion, post-operative ICU admission, anastomotic leakage, lymph node harvesting in the final specimen, and six months follow up and overall survival time after 5-years

NCT ID: NCT05917574 Recruiting - Critical Illness Clinical Trials

A Study to Evaluate the Introduction of New Staffing Models in Intensive Care: a Realist Evaluation (SEISMIC-R)

SEISMIC-R
Start date: June 14, 2023
Phase:
Study type: Observational

Background: Staffing in intensive care units (ICU) has been in the spotlight since the pandemic. Having enough nurses to deliver safe, quality care in ICU is important. However, what the skill mix should be (how many should be qualified nurses or have an ICU qualification) is unclear. Very little research has been done to look at which nursing staff combinations and mix of skills works best in ICU to support patients (described as 'staffing models').Research shows that there is a link between the quality of nurse staffing and poor patient outcomes, including deaths. Aim: Our research plans to look at different staffing models across the UK. This study aims to examine new staffing models in ICU across six very different Trusts. This study will use a research technique called Realist Evaluation that examines what works best in different situations and help to understand why some things work for some people and not others. The design of this approach will help to better understand the use of different staff ratios across different ICU settings. This study will examine what combinations of staff numbers and skills result in better patient care and improved survival rates. The aim is to produce a template that every ICU unit can use. To do this, this study will compare staffing levels with how well patients recover, and seek to understand the decisions behind staffing combinations. Methods: This study will: 1. carry out a national survey to understand the different staff models being used, comparing this against the current national standard (n=294 ICUs in the UK including Scotland) 2. observe how people at work in 6 hospitals (called ethnography), watching how they make decisions around staffing and the effect on patients. The investigators will also conduct interviews (30 interviews plus 30 ethnographic observations) to understand staffing decisions. 3. look at ICU staffing patterns and models, and linked patient outcomes (such as whether people survive ICU) over 3 years (2019-2023) in those hospitals, including with a very different combination of staffing). The investigators will then carry out some mathematical calculations to understand the best possible staffing combinations, and how this varies.

NCT ID: NCT05847803 Recruiting - Intensive Care Clinical Trials

Patient Monitoring in the Intensive Care Unit

Start date: February 5, 2023
Phase:
Study type: Observational

a cross-sectional survey of nurses' perception of patient monitoring in the ICUs

NCT ID: NCT05795777 Completed - Pressure Ulcer Clinical Trials

Examination of the Pressure Ulcers in Intensive Care Patients.

Start date: November 1, 2019
Phase:
Study type: Observational

A pressure sore was localized skin and/or subcutaneous tissue injury, usually caused by pressure alone or a combination of shear and pressure, at bony prominences. Pressure sores, which are an indicator of the quality of health care, increase mortality, morbidity and cost. Pressure ulcers are the most common problem in intensive care patients and should be prevented. In the literature, the incidence of pressure ulcers in intensive care patients is between 1-59.9%. A pressure sore is a localized injury to the skin and/or underlying soft tissue, usually over a bony prominence or associated with medical or other devices. This injury occurs when intense and/or prolonged pressure or pressure is accompanied by shear. Soft tissue tolerance to pressure and shear; temperature and humidity can affect nutrition, perfusion, concomitant conditions, and condition of soft tissue. This study was carried out to determine the prevalence of pressure ulcers and influencing factors in patients hospitalized in the 3rd level intensive care unit of a university hospital. Design: It is a descriptive, prospective, observational type study. Materials and Methods: The sample of the study consisted of 176 patients aged 18 years and above, 24 hours after hospitalization in the intensive care units of a University Hospital. Patient Information Form and Braden Scale for Predicting Pressure Ulcer Risk, Glasgow Coma Scale were used to collecting data. Statistical Package in statistical analysis for the social sciences 20.0 program was used.

NCT ID: NCT05790291 Completed - Intensive Care Clinical Trials

Drug Administration From Enteral Nutrition Tube

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes. However, there are studies reporting errors and complications during drug administration from the enteral nutrition tube. With the planned thesis study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.

NCT ID: NCT05692375 Completed - Intensive Care Clinical Trials

Impact of the Save the Shame! Game on Advanced Life Support Knowledge

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Gamification, listed by the European Resuscitation Council (ERC) as a learning process in its 2021 guidelines, is a new digital innovation tool that brings added value towards motivation that seems to reuse time in a creative way. The aim of this study is to evaluate the impact of the game "Save the shame!" on advanced life support (ALS) knowledge of nurses and physicians in intensive care medicine settings. This is a cross-sectional study following a mixed methodology. In its preliminary phase it follows a qualitative and exploratory methodology, with application of the E-Delphi technique for creation and validation of the "Save the shame! game and validation of the ALS knowledge test. The study subsequently follows the experimental methodology. The investigators expect to confirm the hypothesis that the game "Save the Shame!" has a positive impact on the skills training of health professionals in intensive care medicine settings in a Portuguese hospital center.

NCT ID: NCT05521009 Recruiting - Infection Clinical Trials

Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied

Start date: February 7, 2023
Phase: N/A
Study type: Interventional

Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. . Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not come out. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes is still the most commonly used method. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group. Endotracheal tube fixation methods may increase the risk of infection due to the material from which they are produced.We planned this study to determine whether the endotracheal tube fixation tie or the gauze fixation from my tube fixation materials contains pathogens, and if so, the pathogen hosting rates.

NCT ID: NCT05127109 Recruiting - Surgery Clinical Trials

The PASTDUe Nutrition Ecosystem Project (PASTDUe)

PASTDUe
Start date: April 25, 2022
Phase: Phase 4
Study type: Interventional

This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.