"Post-acute Pickwick Study" (Postacute-Pick-2020)
Acute on Chronic Hypercapnic Respiratory FailureObesity Hypoventilation Syndrome (OHS)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.
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
COPDDespite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking. The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.
Non-Invasive Ventilation After Extubation in Hypercapnic Patients
Respiratory FailureThe purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.
The Effectivity of End-tidal CO2 and Oxygen Reserve Index (ORI) Monitoring in Sedation
HypoxemiaProcedural Sedation2 moreEndoscopic procedures are commonly performed using sedation. As drug-induced respiratory depression is a major cause of sedation-related morbidity, pulse oximetry has been established as standart practice . However SpO2 does not completely reflect ventilation. Capnography is an additional monitoring parameter which demonstrates respiration activity breath by breath. Unfortunately, in the state of moderate or deep sedation during diagnostic or therapeutic procedures (e.g.ERCP or colonoscopies), regular breathing is often disturbed by moving, squeezing, coughing or changes between nose and mouth ventilation causing leakage and therefore artifacts or misinterpretation of data acquired with ETCO2. These problems often restrict the use of side-stream capnography in clinical practice, although the American Society of Anesthesiologists have suggested in their guidelines that extended monitoring with capnography 'should be considered'in deep sedation. The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg). The ORI is an "index" with a unit-less scale between 0.00 and 1.00 that can be trended and has optional alarms to notify clinicians of changes in a patient's oxygen status. When utilized in conjunction with SpO2 monitoring the ORI may extend the visibility of a patient's oxygen status into ranges previously unmonitored in this fashion. The ORI may make pre-oxygenation visible, may provide early warning when oxygenation deteriorates, and may facilitate a more precise setting of the required FiO2 level. In this study we aimed to show effectivity of capnography and ORİ monitoring to avoid respiratory events and hypoxia in sedated endoscopic patients. In this study we targeted totally 300 sedated endoscopy patients. Patients will randomize to two groups. In Group I anaesthesiologis will be able to use all the monitoring, where as in Group II will be blinded for ORİ. We will apply pre-oxygenation to obtain long safe apnea time. Approximately 5 min pre-oxygenation (5L/min via nasal cannula) will be used to reach steady state in oxygen reserve. We defined hypoxemia ; SpO2<95% and severe hypoxemia SpO2≤90%, hypoventilation; rise10 mmHg in ETCO2 compare to baseline, ETCO2≤30 mmHg and flat capnography.
The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
Surgical Wound InfectionSurgery1 moreThe investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.
Hypercapnia and Gas Exchange Under the Avalanche Snow Model (HyperAvaSM)
Accident Caused by Snow AvalancheThe aim of the study is to investigate respiratory parameters of a person in the simulated avalanche snow and consequent use of the measured data for development of a mathematical-physical model of breathing during increasing hypercapnia in the avalanche.
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid...
HypercapniaVentilatory DepressionOpioids can decrease breathing and co-administration of benzodiazepines with opioids can further decrease breathing. It is unknown whether certain other drugs also decrease breathing when co-administered with opioids. The objective of this study is to determine whether certain drugs combined with an opioid decrease breathing compared to breathing with an opioid alone. In order to assess this, this study will utilize the Read Rebreathing method, where study participants breathe increased levels of oxygen and carbon dioxide. The increased levels of carbon dioxide cause the study participants to increase breathing. This increased breathing response can be decreased by opioids and benzodiazepines, and potentially other drugs. Using this procedure, low doses of opioids or benzodiazepines can be administered that have minimal-to-no effects on breathing when study participants are going about normal activities breathing room air, however breathing increases less than expected as carbon dioxide levels are increased. This study will also obtain quantitative pupillometry measurements before and after each rebreathing assessment to allow for comparisons of pupillary changes to ventilatory changes when subjects receive different drugs and drug combinations. This study includes three parts: A Lead-In Reproducibility Phase and two main parts (Part 1 and Part 2). The Lead-In Reproducibility Phase will measure the variability between study participants and between repeated uses of the method in the same study participant within a day and between days. Part 1 will study an opioid alone, benzodiazepine alone, and their combination to show the methodology will detect changes in breathing at low doses of the drugs that are known to affect breathing. Part 2 will assess whether two drugs, selected due to their effects on breathing in a nonclinical model, decrease the breathing response when combined with an opioid compared to when an opioid is administered alone.
Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare...
Chronic Respiratory Failure With HypercapniaChronic Obstructive Pulmonary Disease (COPD)1 moreThe 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.
Influence of Graded Hypercapnia on Endurance Exercise Performance
HypercapniaThe aim of this randomized, single-blind, placebo-controlled crossover trial is to determine the effects of graded hypercapnia (0, 2, and 4% inspired CO2) on endurance performance. Twelve healthy and fit young adults (men and women) will complete this study. Participants will perform experimental trials on 3 separate days (one each breathing 0%, 2%, and 4% inspired CO2-all with normal 21% oxygen). During each trial, they will perform 10 minutes of submaximal treadmill walking exercise and then complete a self-paced 2-mile treadmill run time-trial.
Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Cardiac Surgery Patients
ObesityHyperoxia1 moreThis study aims to evaluate the risk of hyperoxia-induced hypercapnia in post-op obese cardiac surgery patients. It will compare two oxygenation modes in terms of their effect on the arterial partial pressure of carbon dioxide (PaCO2) : manual titration of oxygen delivery for a peripheral oxygen saturation (SpO2) target of > or = 95 % versus automatic titration by a closed-loop system for a SpO2 target of 90%. 15 post-op obese cardiac surgery patients will be recruited and each will receive both interventions (cross-over design). The main outcome will be the PaCO2, which will be compared after each study period. The research hypothesis is that the usual SpO2 target of > or = 95 % is associated with a greater PaCO2 compared with a lesser SpO2 target of 90%.