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Hypoventilation clinical trials

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NCT ID: NCT05506267 Completed - Clinical trials for Respiratory Insufficiency

Development of a Tracheal Sound Sensor

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

An observational study will be conducted in 20 hospitalized surgical patients routinely managed with opioids for anesthesia and post-operative pain control. Trachea Sound Sensor measurements and reference respiratory measurements will be recorded and analyzed to develop diagnostic algorithms that produce a risk-index score that detects/predicts progression from mild hypoventilation, to moderate hypoventilation, to severe hypoventilation due to opioids and other medications that cause respiratory depression. Our current Trachea Sound Sensor (TSS) has a wired Sony commercial microphone integrated into a commercial pediatric stethoscope, coupled to the skin surface over the trachea at the sternal notch. The Trachea Sound Sensor will measure and record the sounds of air moving within the proximal trachea during inhalation and exhalation. The microphone signal will be converted into an accurate measurement of the patient's respiratory rate and tidal volume (during inhalation & exhalation) over time, to determine the minute ventilation trend, breathing patterns, apnea episodes, and degree of snoring (due to partial upper airway obstruction). A commercial respiratory facemask and two pneumotachs (gas flow sensors) will also be used to accurately and continuously measure the patient's respiratory rate and tidal volume (during inhalation & exhalation) to determine the minute ventilation trend, breathing patterns, and apnea episodes. TSS data and reference respiratory data will be collected prior to surgery with the patient breathing normally (baseline), in the Operating Room (OR) during the induction and maintenance of anesthesia, in the Post Anesthesia Care Unit (PACU), and on the general nursing floors of Thomas Jefferson University Hospital (TJUH). The sounds of air flowing through the proximal trachea will be correlated with the reference breathing measurements using signal processing methods to optimize the measurement accuracy of RR, TV, breathing pattern, apnea episodes, and degree of snoring. A commercial accelerometer may be coupled to the skin surface of the neck (with tape) to measure body position and activity level. The TSS and vital sign trend data will be analyzed to produce a Risk-Index Score every 30 seconds with alerts and alarms that warn the patient and caregivers about progressive Opioid Induced Respiratory Depression (OIRD).

NCT ID: NCT05480618 Enrolling by invitation - Clinical trials for Spinal Cord Injuries

Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients

SCOGA
Start date: August 22, 2022
Phase: N/A
Study type: Interventional

This research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (SCI). This research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with SCI and its influence on the cardiovascular system.

NCT ID: NCT05448443 Active, not recruiting - Clinical trials for Obesity Hypoventilation Syndrome (OHS)

Study of AD981 Versus Placebo in Obesity Hypoventilation Syndrome

ATOHS
Start date: June 21, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo-controlled, cross-over, phase II, single center efficacy study of AD981 in patients with obesity hypoventilation syndrome documented by polysomnography (PSG) and transcutaneous, overnight measurement of CO2 (PtcCO2).

NCT ID: NCT05398068 Recruiting - Obesity Clinical Trials

Effects of Exercise Training on Exercise Capacity and Sleep Quality in Patients With Obesity Hypoventilation Syndrome

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

Obesity Hypoventilation Syndrome is defined as a combination of obesity (BMI ≥ 30 kg/m2) and daytime hypercapnia in arterial blood gas analysis (PaCO2 > 45 mmHg) without other pathologies that cause hypoventilation. Symptoms seen in individuals diagnosed with OHS are stated as a feeling of suffocation due to apnea, loud snoring, morning headache and excessive daytime sleepiness. Respiratory mechanics, respiratory muscle performance, pulmonary gas exchange, lung functions and exercise capacity parameters are adversely affected in patients. Early treatment is important so that these negative changes do not lead to worse outcomes. Weight control, bariatric surgery, pharmacological treatment and non-invasive mechanical ventilation (NIMV) are included in the treatment program of OHS patients. The effects of exercise on the treatment program of OHS patients are unknown. Considering all the studies in the literature, the primary purpose of this study is to evaluate aerobic and strength training on exercise capacity and sleep quality in patients with hypoventilation syndrome. The secondary aim is to examine the effect of this exercise training on peripheral muscle strength, emotional state, body composition and quality of life parameters. In addition, the researchers believe that this study will form the basis for further scientific studies on OHS and exercise and will make an important contribution to the literature.

NCT ID: NCT05190458 Not yet recruiting - Clinical trials for Obesity Hypoventilation Syndrome

Evaluation of High Velocity Nasal Insufflation in Management of Respiratory Failure in Patients With Overlap Syndrome

HVNI
Start date: March 2023
Phase: N/A
Study type: Interventional

High velocity nasal insufflation (HVNI), a form of HFNC that utilizes a small bore nasal cannula to generate higher velocities of gas delivery than HFNC which uses large bore cannula, has the ability to accomplish complete purge of extra thoracic dead space at flow rates of 35 litres/min and may be able to provide ventilatory support in patients with respiratory failure in addition to oxygenation support in patients with overlap syndrome. This study aims to evaluate the effectiveness of HVNI compared to NIMV in management of respiratory failure in patients with obesity hypoventilation syndrome and overlap syndrome.

NCT ID: NCT05167201 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Chronic hypercapnic respiratory failure (CHRF) in the context of Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) is associated with increased mortality. The availability and effectiveness of domiciliary Non-invasive ventilation (NIV) treatment (when indicated) is key as this treatment can improve quality of life and reduce health-care costs from associated burden of disease. The emerging obesity epidemic means that there is now increased home mechanical ventilation set-ups in patients with obesity related respiratory failure (ORRF), yet there are no alternative treatments for patients struggling with domiciliary NIV. Domiciliary NHF has been shown to improve health related quality of life in stable CHRF in patients with COPD and improve cost effectiveness yet there are no current studies looking at the use of domiciliary NHF and its outcomes in ORRF. The study aims to deliver a pre and post intervention study evaluating patient reported and clinical outcomes in patients using NHF over twelve weeks, who have either COPD or OHS and have been unable to use domiciliary NIV. The study wishes to address key outcomes such as quality of life, clinical effectiveness, compliance and acceptability with the use of domiciliary NHF in both of these patient populations.

NCT ID: NCT05147922 Completed - Ventilatory Failure Clinical Trials

Neo RQI: The Effect of Neonatal Resuscitation Quality Improvement Cart Booster Training Skills Retention

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

This is a prospective multicenter randomized control trial to assess percentage mask leak six months post instructor led positive pressure ventilation skills training in providers who undergo booster training compared to those who do not undergo any booster training

NCT ID: NCT05084313 Completed - Clinical trials for Autonomic Nervous System

Acute Effects of Deep-Slow Breathing Exercise and Cranial-Visceral Manual Therapy on ANS Parameters in Healthy Adults

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of several manual therapy techniques on autonomic nervous system and to compare it with other groups in the study such as deep-slow breathing group and the control group. The measurements will take place right before and after the intervention to evaluate the effects of one single intervention.

NCT ID: NCT04884165 Completed - COPD Clinical Trials

Remote Monitoring to Improve Low Adherence in Non-invasive Ventilation

READ-NIV
Start date: March 28, 2022
Phase: N/A
Study type: Interventional

Patients are invited to participate in a trial to test a new way to optimise long-term use of non-invasive ventilation using remote monitoring. Breathing difficulties during sleep are frequently treated using home mechanical ventilation, also called non-invasive ventilation (NIV). Breathing difficulties during sleep affect many patients with conditions such as chronic pulmonary obstructive disease (COPD), neuromuscular conditions and obesity hypoventilation syndrome. Left untreated they can cause breathlessness, headaches, sleepiness and lead to hospitalisations and other severe adverse health outcomes. The best available treatment for chronic types of sleep-disordered breathing is NIV. However, not every patient eligible tolerates this treatment because it requires patients to sleep with a nasal or full-face mask that is connected with a tube to a machine. Although NIV is recommended by the National Institute for Health and Clinical Excellence (NICE), many patients who should be on NIV use the treatment insufficiently within months. Using remote monitoring to identify problems with treatment adherence early on may help to identify clinical problems, troubleshoot user- or device-dependent problems, avoid delays in treatment and safe healthcare resources in the long-term. The investigators invite patients who use NIV to participate in this trial when they have difficulties with the treatment (NIV). This study will evaluate compliance and efficacy of a remote monitoring device (T4P device, SRETT, Paris/France) that will be connected to the standard NIV machine to remotely monitor usage. Patients will be randomly assigned to the remote monitoring using NIV for three months at home, or to usual care which is NIV without this monitoring. The primary outcome measure of this study is the improvement in adherence and compliance, as indicated by the average usage of NIV, as well as symptom scores to assess treatment effects.

NCT ID: NCT04839419 Recruiting - Metabolic Syndrome Clinical Trials

Obesity-hypoventilation in Metabolic Syndrom Patients

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

The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.