Active clinical trials for "Hypoventilation"

Rationale: The current standard of respiratory monitoring for patients during deep sedation is continuous pulse oximetry with visual assessment of the patient. Clinical research has demonstrated that depressed respiratory activity is a principal risk factor for hypoxemia during sedation. Capnography may provide early detection of alveolar hypoventilation before hypoxemia has occurred in nonintubated patients and thereby improve patient safety during sedation. Objective: At the Centre for Contraception, Sexuality and Abortion Leiden, abortion procedures are performed under deep sedation using propofol. Patient's monitoring is performed by nurses qualified in patient sedation management, using pulse oximetry and their clinical judgement. The aim of this study is to examine the effectiveness of capnography in early detection of alveolar hypoventilation during deep sedation in comparison to standard monitoring with pulse oximetry in abortion procedures. Study design: This protocol describes a prospective, open, randomized controlled trial with two study arms. All patients receive standard care of monitoring performed by the medical staff. The study investigates whether capnography prevents patients from having respiratory events during deep sedation in abortion procedures by early detection and therapy. Patients randomized to the standard care group receive standard of respiratory monitoring using pulse oximetry. In the capnography arm, respiratory monitoring is performed with pulse oximetry and capnography. Study population: The study population comprises female patients (≥ 18 years) undergoing abortion procedures during first or second trimester pregnancies. Abortion procedures are performed until 22 weeks of gestational age. Capnography: In addition application of capnography during deep sedation with propofol is performed. Before the trial starts, all nurses qualified in patient sedation management and abortion doctors will be trained in assessment of capnography. In the capnography arm, patients' breathing is additionally monitored with capnography. If alveolar hypoventilation is detected medical staff will intervene by arousing the patient, performing chin lift, repositioning the head, provision of oxygen, or abandon from giving additional propofol. These interventions represent the standard of care currently used by the clinical staff to respond to hypoventilation and hypoxemia. Main study parameters/endpoints: The primary outcome is the occurrence of oxygen saturations to ≤90% in the population, as measured by continuous pulse oximetry. Secondary study outcomes include occurrence of oxygen saturations < 80%, dose of administered propofol, arousal or movement of the patient during the procedure, airway interventions, early termination of the procedure due to respiratory problems, episodes of bradycardia, and administration of atropine. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks related to the conduct of this study are negligible and the burden minimal. Patients in both groups receive the current standard of care. Patients randomized in the capnography group could get benefit from the addition of capnography to the monitoring by early detection of alveolar hypoventilation. Capnography is a noninvasive measurement by means of a cannula under the nose, which before the sedation may tickle, but during sedation no inconvenience is expected.

We propose to carry out a large multicentric, multinational, randomized controlled trial with two phases (two sequential randomized controled trials) to answer two questions: 1) Should hospitalized patients with recently diagnosed OHS be discharged from the hospital on an auto-titratable NIV treatment until the diagnosis of OHS is confirmed in 3 months? 2) Is the long-term effectiveness of outpatient titrated CPAP non-inferior to titrated NIV in ambulatory patients with OHS 3 months after hospital discharge? Clinical practice, multicenter open-label controlled randomized clinical trial with preset allocation rate (1:1) with two parallel-groups conducted in centers from Spain, France, Portugal and USA. The study will have two phases with two randomizations. The first phase will be a superiority study and the second phase will be a non-inferiority study.

The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy.

Comorbidities associated with severe obesity determine an important public health problem. Few methods are considered potentially effective for the treatment of severe obesity and the clinical relevance of bariatric surgery is growing, as well as the number of procedures performed. The insertion of the physiotherapist in the multiprofessional team responsible for performing the surgical procedure is essential from the preoperative screening and evaluation to the prevention and treatment of postoperative complications. Therefore, the physiopathological aspects involved with severe obesity, the technical aspects and risks of the surgical procedure, as well as the physiotherapeutic techniques that have scientific proof must be known by the physiotherapist responsible for the surgical follow-up of the patient. In this context, the use of non-invasive ventilation (NIV) in the postoperative period of bariatric surgery has ample therapeutic potential. The present research project aims to evaluate the immediate prophylactic use of NIV on the respiratory and functional recovery of the patients.

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV. In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. The use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. This study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can safely prevent desaturation events in children under anesthesia.

The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.

Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.

The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education. e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.