Respiratory Therapy

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

Researchers are studying lung mechanics during the early phase of mechanical ventilation in intensive care and during general anesthesia in surgical patients. The study aims to better understand lung compliance and transpulmonary driving pressures using a new, non-invasive PEEP-step method. This method could improve how ventilator settings are personalized to reduce lung injury and complications, addressing a gap in data collected during the critical first hours of ventilation. The study observes two groups: ICU patients receiving ventilator treatment and patients undergoing general anesthesia for surgery. In both groups, a PEEP-step method involves adjusting positive end-expiratory pressure (PEEP) up and down in one or two steps while measuring changes in lung volume and pressures. This is done directly after intubation and repeated during ventilation or surgery when clinical events occur, using specialized software that analyzes data from standard ventilator monitoring equipment. Participants will be monitored continuously during ventilator treatment or surgery. Measurements include lung elastance and transpulmonary driving pressure, collected before, during, and after respiratory care. Clinical data such as blood gases and ventilator settings are recorded without any invasive procedures. The study assesses lung function changes over time, ventilator duration, and postoperative complications, aiming to enhance ventilator therapy and patient outcomes. Total participation time varies with clinical course.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Cystic fibrosis (CF) is a rare inherited disease that affects multiple organs, especially the lungs and digestive system. It is most commonly observed in Caucasians, but few cases have been reported among the large Chinese population. This research aims to accurately assess the prevalence of CF in China, along with the disease status, diagnosis and treatment approaches, quality of care, and health-related outcomes for Chinese patients. This study is observational and does not involve experimental treatments or interventions. It collects clinical information about Chinese patients diagnosed with CF, following the World Health Organization's diagnostic criteria. The study will monitor these patients over time to understand their lung function and related health measures. Participants will be evaluated for lung health changes, including spirometry tests measuring FEV1 and FVC, over a 10-year period. Data on genetics, clinical symptoms, treatments, and outcomes will be gathered to provide a comprehensive view of CF in China. Informed consent is required, and patients must be stable without recent respiratory infections to participate.

Pulmonary lymphangioleiomyomatosis (LAM) is a rare lung disease characterized by widespread cystic changes and almost exclusively affects women. This research aims to accurately determine how common LAM is in China and to evaluate the current disease status, diagnostic methods, treatment approaches, quality of care, and health outcomes for patients. The study is observational and will collect data over a period of four years from approximately 800 participants. This study is a national registry that gathers clinical information on Chinese women diagnosed with LAM. It will not involve any experimental treatments but will monitor patients' health and treatments they receive in routine care. The primary outcome is to track the annual change in lung function, specifically measuring forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Secondary outcomes include changes in lung gas exchange ability, occurrence of serious health events such as bleeding or lung complications, pregnancy outcomes, tumors, lung transplants, deaths, and side effects from long-term rapamycin treatment. Participants will be followed for up to ten years with regular pulmonary function tests and health assessments. The study includes collecting data on major health events and adverse effects related to treatment over this time. Researchers will analyze these data to better understand LAM progression and outcomes in Chinese patients. The study requires participants to provide informed consent and be available for follow-up visits to contribute valuable information about this rare disease.

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs score’s predictive ability. The total study duration extends until the end of 2026.

Researchers are exploring two strategies for setting pressure support levels in patients receiving pressure support ventilation (PSV) in intensive care units. The study focuses on adults with acute hypoxic respiratory failure who need mechanical ventilation. It aims to compare the traditional method based on tidal volume (VT) and respiratory rate (RR) with a newer method using the pressure muscle index (PMI), which may better reflect patient inspiratory effort. This pilot trial will examine clinical outcomes and how well clinicians adhere to these strategies to guide future larger studies. The trial involves two treatment periods at two centers using a sequential cluster crossover design. The first 4-week period uses the VT/RR-targeted pressure support settings, followed by a 4-week washout, then a 4-week PMI-targeted period. In the VT/RR group, pressure support is adjusted to keep VT between 6 and 8 ml/kg predicted body weight and RR between 20 and 35 breaths per minute. In the PMI group, pressure support is adjusted to keep PMI between 0 and 2 cmH2O. Both groups receive standard mechanical ventilation care, including sedation and analgesia management, with adjustments made twice daily during PSV. Participants will be monitored daily until weaning, death, discharge, or 28 days after randomization. Data collected include ventilator settings, respiratory and hemodynamic parameters, sedation and analgesia levels, and clinical outcomes such as duration of mechanical ventilation and mortality. The study also includes clinician surveys about the acceptability and feasibility of the PMI-based strategy. This comprehensive approach will help assess the practicality of PMI-targeted pressure support in critical care settings.

Many premature newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure (NCPAP). When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the baby's mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches: using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.

Researchers are evaluating the effects of heated humidified high flow nasal cannula (HFNC) oxygen therapy compared to conventional nasal cannula oxygen therapy in patients with gynecologic tumors who are at high risk for post-operative pulmonary complications (PPC). The study focuses on women undergoing gynecological surgery and aims to measure the occurrence of PPC such as postoperative hypoxemia, atelectasis, and pneumonia. Secondary outcomes include improvements in postoperative oxygenation, antibiotic use, length of hospital stay, and any adverse events related to oxygen therapy. Participants are randomly assigned to one of two groups: the HFNC group receives heated humidified high flow nasal cannula oxygen therapy on the day of surgery and the first day after surgery, with oxygen saturation maintained between 92% and 95%. The control group receives conventional nasal cannula oxygen therapy during the same time frame, also maintaining oxygen saturation at 92% to 95%. Both groups have chest CT scans reviewed 36 to 48 hours after surgery. The HFNC device can provide oxygen concentrations ranging from 21% to 100% with heated and humidified gas at 37°C and a maximum flow of 70 liters per minute. During the study, participants will be monitored for postoperative pulmonary complications over seven days after surgery. Researchers will also assess total hospitalization days, oxygen therapy usage, antibiotic use, postoperative oxygenation, and any adverse events within two to seven days post-surgery. The study includes scheduled chest CT scans and continuous oxygen saturation monitoring to track participant outcomes. The study is sponsored by Sichuan Cancer Hospital and Research Institute and is expected to continue until the end of 2025.

Researchers are studying the immediate and long-term effects of structured breathing exercises on mental health symptoms such as anxiety, depression, stress, and sleep quality. The study focuses on healthcare professionals experiencing burnout and aims to assess how these breathing practices might support their mental well-being. This behavioral intervention is sponsored by Mayo Clinic and targets adults aged 18 to 85 years. Participants will engage in self-guided structured breathing sessions lasting 15, 30, or 36 minutes, tailored to their personal skill level. The study monitors the feasibility, acceptability, and appropriateness of these breathing exercises over a four-month period. The intervention is delivered via a mobile app, allowing participants to practice breathing exercises on their own schedule. During the study, participants will be assessed on recruitment ease, retention, mobile app engagement, satisfaction with the breathing intervention, and adherence to the program. Researchers will collect data through mobile app usage metrics and self-reported measures to evaluate how well the intervention fits into the participants' routines. The total participation time for each individual is four months, during which their progress and experience with the breathing practice will be closely monitored.