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NCT ID: NCT05575089 Recruiting - Clinical trials for Bariatric Surgery Candidate

Inspiratory Muscle Training and Pulmonary Function in Patients Submitted to Bariatric Surgery

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

Obesity is defined as a body mass index greater than or equal to 30 kg / m2 and represents a public health problem that affects the world population. It is associated with a higher frequency of cardiovascular, metabolic diseases, and respiratory morbidities, which affect the quality of life of patients. Its treatment comprises different strategies, however, due the conventional treatments, surgical treatment has been the most sought after today. Objectives: To evaluate the effectiveness of preoperative inspiratory muscle training in the evolution of respiratory muscle strength in patients undergoing bariatric surgery. Methodology: Randomized clinical trial. All patients will be assessed in the pre operative period and randomized into 2 groups: control group and intervention group. The main variables are maximum inspiratory and expiratory muscle strength (MIP and MEP), peak cough flow (PCF) and pain. Control group will perform proposed respiratory physiotherapy, aerobic exercises and use of incentive inspirometry, the intervention group will perform proposed physiotherapy, aerobic exercises and use of Powerbreathe for inspiratory muscle training. Both groups will perform 10 non consecutive face-to-face physiotherapy sessions ( up 30 days before surgery). After the surgical intervention, they will be evaluated on the first and 30th postoperative days in relation to the same variables and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. After the intervention, they will be evaluated on the second postoperative day for days of hospitalization and pulmonary complications. Statistical Analysis: Sample calculation performed through a previous study: 42 patients per group. Categorical variables will be summarized in absolute and relative frequencies (percentages). Information regarding numerical variables will be expressed as means, standard deviations or medians, and interquartile range, depending on the distribution of the variable. All variables will be tested in relation to their distribution. To analyze the results between groups will be used the mixed linear models and for intragroup analysis, two-way ANOVA (time and group) for the following variables: MIP and MEP, PCF and pain. Expected results: Preoperative inspiratory muscle training can maintain/improve respiratory muscle strength until the moment prior to surgery, thus better preparing the patient for the condition of surgical stress, in addition to decreasing the incidence of pulmonary complications during the hospitalization period and / or in the 30 postoperative days.

NCT ID: NCT05574777 Recruiting - Obesity Clinical Trials

Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity

Start date: April 13, 2023
Phase: N/A
Study type: Interventional

This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity Class III participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary endpoint device or procedure related occurrence of complications according to Clavien-Dindo classification will be determined. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 6 months to assess the outcome of the GMA procedure.

NCT ID: NCT05574556 Completed - Bone Fracture Clinical Trials

Electromiographic Analysis of the Quadriceps After Trauma

Start date: January 10, 2021
Phase:
Study type: Observational

The lower limb is the region most affected by fractures in the human body. The magnitude of the trauma can cause injuries to structures adjacent to the fracture, promoting joint instability and consequently predisposition to osteoarthritis. The treatment of fractures can be performed conservatively or surgically, and one of the consequences of the surgery is arthrogenic muscle inhibition, which presents itself as a marked muscle weakness due to inhibition of the central nervous system that prevents adequate muscle activation. However, recruiting the quadriceps is the most commonly used goal to determine the patient's return to activities. Physiotherapy has several resources for the functional activation of the quadriceps muscle, such as neuromuscular electrostimulation (NMES), verbal command of muscle activation and neuromatrix techniques. Thus, the objective of this study will be to analyze, by means of electromyography, the myoelectric activity of the quadriceps muscle in individuals undergoing physical therapy intervention, affected by some fracture of the lower limb.

NCT ID: NCT05573854 Completed - Safety Issues Clinical Trials

Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein

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

Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.

NCT ID: NCT05573568 Completed - Healthy Volunteers Clinical Trials

Clinical Study of DMT in Healthy Adults

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.

NCT ID: NCT05573152 Completed - Hypothermia Clinical Trials

Pre Warming Protocol Implementation in Operation Room

Start date: July 2015
Phase: N/A
Study type: Interventional

Literature establishes that warming with a heated blanket before and during the operation is effective in the prevention of perioperative hypothermia, both in general anesthesia as well as spinal anesthesia. However, the trials have still not presented us with objective protocols to standardize this routine in the surgical centers. The study aims to assess the adoption and reproduction of the implementation of the warning device by the nursing team immediately after the patient's entrance in the operating room, even before the entrance of the anesthesiologist.

NCT ID: NCT05573139 Completed - Muscle Weakness Clinical Trials

Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength

Start date: March 20, 2021
Phase: N/A
Study type: Interventional

INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Among them, a national equipment was developed, but its reliability and validation are yet to be confirmed, compared to equipment already used, such as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor® device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165), already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS: A total of 26 recruits of both sexes were selected. Muscle strength was measured by Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors; flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was collected 3 times, and then the average was calculated.

NCT ID: NCT05572853 Completed - Clinical trials for COVID-19 Respiratory Infection

Respiratory Muscles Electromyography in Patients With Covid-19

EMG-COVID
Start date: February 25, 2021
Phase:
Study type: Observational

This research was characterized as a cross-sectional observational study, following the recommendations of the STROBE instrument. Therefore, it was conducted in the Intensive Care Unit of Otávio de Freitas Hospital (HOF) in Recife/PE, with patients over 18 years old who had a clinical diagnosis of COVID-19, using two methods of oxygen therapy (Nasal Oxygen Therapy) and (non-rebreather mask). Consequently, clinical evaluations were performed regarding the disease, severity of COVID-19, perception of respiratory effort, and electromyography of respiratory muscles. 1. Leading Question: How does the recruitment pattern of diaphragmatic and extradiaphragmatic muscles in patients with acute hypoxemia caused by COVID-19 behave when assessed through EMGs, considering the SpO2/FiO2 ratio as the analysis parameter? 2. Leading Question: Is there a relationship between the respiratory work estimated by electromyographic activity of diaphragmatic and extradiaphragmatic muscles in patients with acute hypoxemia due to COVID-19 and the parameters of respiratory frequency and levels of acute hypoxemia measured by the SpO2/FiO2 ratio? The rationale for this study is that the COVID-19 pandemic has caused significant impacts on global public health due to the high volume of respiratory complications in the face of a limited supply of healthcare resources, consequently leading to high mortality. Complications are initially manifested by acute hypoxemia associated with COVID-19 infection, sometimes silent upon visual inspection or using less sensitive methods. This complicates the management of compensatory respiratory work for hypoxemia, even with oxygen therapy support. Respiratory muscle recruitment involves aspects of inspiratory effort and ventilatory mechanics. Recognizing the presence and recruitment pattern of muscles involved in a timely manner can contribute to the clinical management success rate of individuals affected by respiratory dysfunction associated with COVID-19, especially at different levels of acute hypoxemia. Surface electromyography is a non-invasive, low-risk tool compatible with the analysis of respiratory muscle recruitment patterns. However, there are no studies describing this pattern in COVID-19 patients, serving as a basis for personalized therapeutic strategies.

NCT ID: NCT05572736 Active, not recruiting - Heart Failure Clinical Trials

Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart Failure

PhysioSync-HF
Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of conduction system pacing versus biventricular pacing on death, worsening heart failure, and left ventricular ejection fraction in patients with chronic heart failure with reduced ejection fraction and left bundle branch block.

NCT ID: NCT05572515 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-9
Start date: March 29, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.