Clinical Research Directory

A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients

To evaluate the feasibility of a speaking-valve-based decannulation protocol in tracheostomized stroke patients

A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness

To evaluate the feasibility of a standardized tracheostomy decannulation protocol for patients with prolonged Disorders of Consciousness (pDoC) .

Tracheostomy Practices in Adult Intensive Care Units: A Multicenter Point-Prevalence Study in Izmir (IZ-TRACH)

This completed observational study describes physician-reported reasons for postponement among adults with an established tracheostomy who were present in participating intensive care units (ICUs) on a single survey day. The survey was conducted in eleven adult ICUs in six hospitals in Izmir, Turkey, on 8 September 2025. The census comprised 282 adults; 46 had a tracheostomy. All 46 contribute to the prevalence numerator. The main descriptive sample comprises 42 patients whose tracheostomy was established during the current admission; four patients with tracheostomies created before admission are excluded from patient-level clinical and outcome summaries. Previous clinical and procedural information was collected retrospectively, and postponement reasons were obtained from primary treating physicians. Mortality was assessed 30 days after the index day, on 8 October 2025. Analyses describe reason categories, total intubation-to-tracheostomy intervals, patient and procedural characteristics, recorded complications, and post-index in-hospital mortality. They cannot establish the duration attributable to family decision-making, preventability of postponement, or effects on outcomes. Registration and this clarification occurred after study completion; no prospective specification of the revised analyses is claimed.

No DIET Trial: Dogmatic Interruption of Enteral nuTrition

There is currently limited guidance on when to hold nutritional supplementation through for patients, who are receiving tube feeding, undergoing surgical procedures. This study aims to investigate which time would be the best to stop nutrition, if at all, before undergoing a surgical procedure.

Trachphone vs Warm Air Humidification for Acute Trache Patients on ICU

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.

Boosting Resources for Tracheostomy Care at Home

The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are: * What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home? * How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge? Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.

Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation

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.

Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies

The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims: Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention. Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention. The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist. The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve. Criteria for the successful use of the speaking valve for 30 minutes: 1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc. 2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline \< 5%. 3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.

Effect of Structured Education for Family Members of Intensive Care Patients Undergoing Tracheostomy

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.

Comparison of Ventilatory Effects of Ultrasound-Guided Versus Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy

Percutaneous dilatational tracheostomy (PDT) is a commonly performed procedure in intensive care units for patients requiring prolonged mechanical ventilation. Fiberoptic bronchoscopy (FOB) and ultrasonography (USG) are frequently used to guide PDT in order to improve procedural safety. However, the effects of these guidance techniques on ventilation parameters during the procedure remain unclear. This retrospective observational study aims to compare the effects of FOB-guided and USG-guided percutaneous dilatational tracheostomy on ventilation parameters in mechanically ventilated adult intensive care unit patients. Changes in arterial blood gas parameters and ventilator settings during and after the procedure will be evaluated. The findings of this study may help clinicians better understand the physiological effects of different PDT guidance techniques and support informed decision-making in clinical practice.

Trcheal High-flow for Weaning From Mechanical Ventilation

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.

Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients

This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination, frequent dressing changes, tube displacement, and patient discomfort. The novel fixation device was designed to provide stable tube fixation, protect the cervical skin, facilitate wound care, and improve patient comfort. A total of 150 eligible patients who underwent tracheostomy were randomly assigned to a treatment group or a control group. Patients in the control group received routine tracheostomy care and conventional fixation. Patients in the treatment group received the novel self-adhesive bidirectional tracheostomy tube fixation device in addition to routine tracheostomy care. The study assessed whether the novel fixation device could reduce tracheostomy-related complications, improve nursing efficiency, reduce the frequency and duration of wound care, improve neck comfort, and maintain safe tracheostomy tube fixation.

Use of TrachPhone in Tracheostomized Patients

The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma. The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.

PDCA-Based Precision Nursing for Stroke Patients With Tracheostomy

Stroke patients undergoing tracheostomy are at high risk of pulmonary complications because tracheostomy bypasses the normal upper airway defense mechanisms and increases the risk of airway colonization and infection. Although routine nursing care is widely used, a standardized quality improvement strategy for airway management remains lacking. This single-center, prospective, randomized, single-blind controlled trial aims to evaluate whether a PDCA (Plan-Do-Check-Act) cycle-based precision nursing program improves clinical outcomes in stroke patients with tracheostomy compared with routine nursing care. Eighty eligible participants will be randomly assigned in a 1:1 ratio to receive either the PDCA-based precision nursing intervention or routine nursing. The primary outcome is the incidence of pulmonary infection. Secondary outcomes include sputum viscosity, arterial blood gas parameters (PaO₂, PaCO₂, and oxygenation index), nursing satisfaction, and safety outcomes including unplanned extubation, incision infection, and airway mucosal injury.

Standardized Tracheostomy Weaning Protocol for Prolonged Mechanical Ventilation

This study evaluated the feasibility and clinical outcomes of a standardized weaning protocol for tracheostomized patients requiring prolonged mechanical ventilation. The protocol was delivered in a specialized weaning unit of a tertiary rehabilitation hospital and combined early noninvasive ventilation, progressive high-flow oxygen therapy through the tracheostomy tube, spontaneous breathing trials when appropriate, and stepwise reduction of ventilatory support. The main outcome was successful liberation from mechanical ventilation within 60 days.

Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients

Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury). However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily. This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.

Outcomes After Tracheal Cannula Removal

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).

Invasive Home Ventilation in Denmark

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.

Impact of Information and Participation on Decision Time for Tracheostomy or PEG in ICU Families

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.

"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"

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.

Feeding Difficulties and Quality of Life in Children With Tracheal Cannula

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.

SV With TTPEE Measurement Predicts Upper Airway Patency in Prolonged Tracheostomy Patients

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.

Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients

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.