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Critical Illness clinical trials

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NCT ID: NCT06419699 Not yet recruiting - Muscle Weakness Clinical Trials

CPAx: Responsiveness and Minimal Clinically Important Difference

Start date: May 2024
Phase:
Study type: Observational

Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.

NCT ID: NCT06411873 Not yet recruiting - Enteral Nutrition Clinical Trials

The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is o determine the feasibility and efficacy of high enteral protein in critically ill postoperative children. It will also learn about the safety of high enteral protein for critically ill postoperative children. The main questions it aims to answer are: Does high enteral protein improve nitrogen balance in critically ill postoperative children? Does high enteral protein reduce levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children? Researchers will compare high enteral protein to a standard enteral protein to see if high enteral protein works to improve nitrogen balance and reduces levels of Intestinal Fatty Acid Binding Protein (I-FABP) in critically ill postoperative children. Participants will: Take high enteral protein or standard enteral protein for 72 hours The nitrogen balance and I-FABP levels will be assessed both before and after enteral feeding. Monitoring and reporting of adverse events and serious adverse events will be conducted in accordance with good clinical practice guidelines.

NCT ID: NCT06411561 Not yet recruiting - Dementia Clinical Trials

A Multi-Modal Combination Intervention to Promote Cognitive Function in Older Intensive Care Unit Survivors

SLEEP-COG
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Up to 25% of intensive care unit (ICU) survivors experience cognitive impairment comparable in severity to mild Alzheimer's disease and related dementias after hospital discharge. Older ICU survivors (ages 60 and older) are at highest risk for delirium and subsequent cognitive impairment, which contribute to higher risk for cognitive decline related to Alzheimer's disease and related dementias. Sleep and activity are essential for recovery from critical illness, yet ICU survivors experience both sleep deficiency and profound inactivity. About 75-80% of ICU patients experience circadian dysrhythmia, which contributes to cognitive decline and increases likelihood of developing Alzheimer's disease and related dementias. The scientific premises of the proposed study are: 1) a combined sleep promotion and cognitive training intervention will have synergistic effects to mitigate the risk of cognitive impairment and development of Alzheimer's disease and related dementias in older ICU survivors; and 2) chronotherapeutic timing of interventions (i.e., adjusting timing of interventions according to circadian rhythm) may improve intervention efficacy.

NCT ID: NCT06394947 Not yet recruiting - Critical Illness Clinical Trials

Fluid Challenge in Intensive Care The FENICE II Study

FENICE II
Start date: January 1, 2025
Phase:
Study type: Observational [Patient Registry]

Fluids are considered the primary treatment for critically ill patients admitted to the intensive care unit (ICU), aiming to replace losses and or to enhance venous return, stroke volume, and consequently, cardiac output and tissue oxygen delivery. The modalities, volumes, and targets employed to titrate fluid therapy vary significantly in current clinical practice, as shown by the original FENICE study 10 years ago. FENICE studied how fluid challenges are given at the bedside. Very little is known about how this practice has changed since, how fluid administration (maintenance) is performed in general, and how the modality may impact outcomes. FENICE II is designed to explore these issues. Objectives: To provide a comprehensive global description of fluid administration modalities during the initial days of ICU admission and to explore any association between fluid administration characteristics and clinical outcomes. To describe the fluid challenge administration modality and appraise the use of variables and functional hemodynamic tests to guide bolus infusion.

NCT ID: NCT06393179 Not yet recruiting - Critical Illness Clinical Trials

Epidemiology and Treatment Strategy of Open Respiratory Phenotype in Critically Ill Patients

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

Monitoring airway pressure is essential for patients with mechanical ventilation. However, static airway pressure does not reflect alveolar pressure at all. Airway pressure is supposed to completely interrupt the communication between proximal airway opening and the distal alveolar and/or small airway structures. In this condition, some alveoli may still be inflated but do not communicate with proximal airways and auto-PEEP will give a biased estimated of mean alveolar pressure. To be note, distinguishing the airway closure and alveolar collapse can be challenging at times. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, which may help us to identify the airway closure and alveolar collapse. Meanwhile, the quasi-static PV curve can only reflects a global behaviour of the lung, while EIT may be a useful tool to assess the regional information on airway closure and alveolar collapse.

NCT ID: NCT06382727 Not yet recruiting - Critical Illness Clinical Trials

CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care

CONTINUE
Start date: April 2024
Phase: N/A
Study type: Interventional

Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally. The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation). The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN. This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation.

NCT ID: NCT06376747 Not yet recruiting - Iatrogenic Anaemia Clinical Trials

The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients

PEDPBM
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system.

NCT ID: NCT06374225 Not yet recruiting - Critical Illness Clinical Trials

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

SAVE-O2 AI
Start date: April 2024
Phase: N/A
Study type: Interventional

This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).

NCT ID: NCT06373068 Not yet recruiting - Critical Illness Clinical Trials

Association Between Resuscitation Orders and Mortality in ICU Patients

Start date: May 2024
Phase:
Study type: Observational

The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.

NCT ID: NCT06364280 Not yet recruiting - Critical Illness Clinical Trials

Pediatric Prehospital Airway Resuscitation Trial

Pedi-PART
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].