Tracheostomy

A tracheostomy is a surgical opening made in the windpipe (trachea) through the neck to help a person breathe. A tube is placed in the opening to keep it open. As a result, the air reaching the lungs can be cooler, drier and less well filtered. This can lead to thicker mucus, coughing, difficulty clearing secretions, and an increased risk of chest infections or breathing problems caused by mucus blockages. To help replace some of the moisture normally provided by the nose and throat, humidification is often used. Different methods of humidification are used in clinical practice, although approaches may vary between healthcare centres. Although Heat and Moisture Exchangers (HMEs) have been available for many years for people with a tracheostomy who breathe independently, their use remains limited and varies across healthcare settings. Existing research suggests that HMEs are generally well tolerated and may help keep airway secretions thinner and easier to clear, however the evidence available is limited and further research is needed for a better understanding of the clinical benefits and limitations. The purpose of this study is to compare two humidification methods used for tracheostomy patients receiving ventilator support in critical care: the TrachPhone, a single use Heat and Moisture Exchanger (HME) device and warm air ventilation humidification. The investigators want to understand whether either method offers advantages in secretion management, patient safety, comfort, and clinical outcomes.

Some critically ill patients need a breathing tube placed directly into the windpipe (tracheostomy) because they require long-term help from a breathing machine. Before this tube can be safely removed (decannulation), medical team need to confirm the patient is ready to breathe on their own through the nose and mouth again. The most common way to check this is a "capping trial," in which the tube is blocked so air must pass through the upper airway, similar to normal breathing. However, because the tube itself remains in place during this test, it narrows the airway and may make breathing harder than it would be if the tube were actually removed. This could cause some patients to fail the test even though they are truly ready for the tube to come out, leading to unnecessary delays. This study will compare the standard capping trial with a new approach that instead adds extra tubing (dead space) to the breathing circuit, without blocking the airway, to more closely copy the breathing effort patients will experience once the tube is removed. Each participant will undergo both methods, in random order, during a single study day, with breathing effort, muscle activity, and comfort measured during each method and again after the tube is actually removed. The goal is to determine which method more accurately predicts how a patient will actually breathe once the tracheostomy tube is taken out.

Family members of patients undergoing tracheostomy in the intensive care unit frequently experience anxiety, uncertainty, and concerns regarding the patient's care. This randomized controlled trial aims to evaluate the effect of structured education provided to family members of patients undergoing tracheostomy in the intensive care unit on state anxiety, psychological well-being, and satisfaction with care. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive structured education before tracheostomy, whereas the control group will receive routine information. Outcomes will be assessed before tracheostomy, on the first day after tracheostomy, and one week after the procedure.

Multicentre randomized trial to determine whether tracheal high-flow nasal oxygen can improve weaning outcome vs. conventional oxygen therapy in critically ill tracheostomized patients who are hypoxemic.

This longitudinal observational study involves an integrated knowledge translation (IKT) approach involving key stakeholders in the project team to evaluate the tracheostomy management in patients hospitalized in the Swiss Paraplegic Centre Nottwil (SPC).

The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.

Decisions regarding tracheostomy and percutaneous endoscopic gastrostomy (PEG) in the intensive care unit (ICU) are frequently associated with substantial uncertainty, decisional conflict, and psychosocial burden among patients' relatives. Inadequate or non-tailored information may negatively influence anxiety levels, decision satisfaction, and subsequent adaptation to care responsibilities. Differences in communication patterns and educational background may further affect how families perceive the risks, benefits, and long-term implications of these procedures. This prospective study aims to evaluate the impact of relatives' educational level and different information delivery methods on anxiety, decision satisfaction, and the overall decision-making process related to tracheostomy and PEG in the ICU setting. The findings are expected to contribute to the development of structured, education-level-tailored information strategies to improve shared decision-making and family-centered care in critical care practice.

Study Objective: This observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications. Study Population: The study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden. Research Questions: 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods: Children scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication. After the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol. The airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.

The over all goal of this observational study is to study if there is an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula. The main questions it aims to answer are 1. What is the incidence of feeding difficulties in children with tracheostomy and what type of feeding difficulties affect these children? 2. How do children with a tracheal tube and their parents assess their quality of life measured through PedsQL? 3. Is there an association between the presence of feeding difficulties and self-assessed quality of life in children with tracheal cannula? Quality of life will be assessed in an interview using the PedsQL instrument generic module 4.0. Swallowing difficulties will be assessed through evaluations based on The Montreal Children's Hospital Feeding Scale.

Background: International studies have proposed a cough peak flow (CPF) of ≥160 L/min as a reference threshold for safe decannulation. However, this measurement requires prior removal of the tracheostomy tube, which is often difficult for Chinese patients and their families to accept due to cultural and safety concerns. Additionally, there is a lack of rapid, user-friendly, and widely applicable quantitative tools in clinical practice within ICUs or rehabilitation specialties in China. Moreover, the heterogeneity among domestic patient populations with different underlying conditions (such as neuromuscular diseases, spinal cord injuries, stroke, and respiratory failure) makes it challenging to apply a single foreign-derived indicator. In our center's prospective study from 2019 to 2022(Respiratory Research 2024;25:128), the investigators proposed and preliminarily validated that a cough flow measured with tracheostomy tube and speaking valve (CFSV) \>100 L/min could serve as a threshold for safe decannulation. Among 193 patients with long-term tracheostomy tubes, 105 were decannulated based on this threshold, with a success rate of 98.1%. Only two cases required reintubation within 48 hours (1.9%), and the six-month reintubation rate was 2.9%, which is significantly better than previously reported domestic and international data (reintubation rates of 5-15%). For patients with insufficient CFSV, after an average of 26 days of individualized cough enhancement rehabilitation, 91% achieved the threshold and ultimately succeeded in decannulation. This suggests that 100 L/min may be a more physiologically appropriate threshold for Chinese (and even East Asian) populations with indwelling tracheostomy tubes, and that CFSV combined with systematic rehabilitation interventions can significantly improve decannulation rates. However, these conclusions are derived from single-center data with a limited sample size, and the diversity of diseases and regional variations in medical standards may affect generalizability. Therefore, there is an urgent need for multicenter, large-sample prospective studies to validate the effectiveness, accuracy, and feasibility of CFSV \>100 L/min as a quantitative standard for safe decannulation.

The aim of this study is to evaluate the feasibility of predicting upper airway patency in patients with prolonged tracheostomy using a non-invasive method combining speaking valve (SV) and transtracheal end-expiratory pressure (TTPEE) through a multicenter study.

The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program. The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families.

This study aimed to determine the effects of listening to fairy tales, listening to fairy tales from the mother's voice, and watching cartoons on pain, comfort, and physiological parameters during tracheostomy care of children receiving palliative care.

Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).

Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy. The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.

This study aims to evaluate how well tracheotomized patients can cough before and after their tracheostomy tube is removed. Cough strength is measured using two different tools-Peak Flow and Lorio. Researchers want to find out if the cough measurement taken before removing the tube can help predict how effective the patient's cough will be afterward. The study will also explore factors that might influence cough strength and compare the usefulness of the two tools. Additionally, it will assess how patients feel about using these devices and the role of diaphragm ultrasound in predicting cough effectiveness.

High-flow nasal oxygen therapy offers benefits like precise oxygen delivery, flow-related positive end-expiratory pressure generation and improved lung function. High-flow oxygen therapy can be applied via tracheostomy as high-flow tracheal oxygen. While high-flow tracheal oxygen has been used to facilitate weaning, it has diminished physiological effects due to bypassing upper airways. To enhance its effectiveness, researchers developed a modified high-flow tracheal oxygen tube with a smaller expiratory end diameter to increase airway resistance and pressure. This is a prospective randomized crossover study that aims to compare the physiological effects of standard and modified high-flow oxygen therapy in tracheostomized patients.

The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are: * What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group? * What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system. 4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.