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Tracheostomy clinical trials

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NCT ID: NCT06201130 Recruiting - Clinical trials for Microbial Colonization

Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

Start date: December 20, 2023
Phase:
Study type: Observational

Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.

NCT ID: NCT06120790 Recruiting - Tracheostomy Clinical Trials

Investigation of a 3 oz Water Protocol on Patients With Tracheostomies

Start date: May 6, 2024
Phase:
Study type: Observational

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).

NCT ID: NCT06047665 Recruiting - Tracheostomy Clinical Trials

Outcomes After Tracheal Cannula Removal

Dekan
Start date: August 25, 2023
Phase:
Study type: Observational

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).

NCT ID: NCT06027866 Recruiting - Communication Clinical Trials

A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies

SRAVI
Start date: January 26, 2023
Phase:
Study type: Observational

Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an incision at the front of the neck to insert a breathing tube directly into the airway. The tube sits in place in the airway using an inflated air-filled cuff. This means that no airflow is directed up and out past the vocal cords through the voice box, and speech is not possible. Being unable to speak can cause distress to patients and may place them at an increased risk of harm if they are unable to express their wishes or needs. It can also increase stress for relatives and healthcare staff as they try to understand what patients are trying to say. Usually when patients cannot talk, staff use different items to help, like a pen and paper. A new communication device that runs on a smartphone or tablet has recently been developed. It is for patients with tracheostomies and works by reading lip movements and translating them into words on the device screen. The aim of this study is to find out if providing adult acute and critical care patients who have a tracheostomy with the use of this lip-reading device could improve how they communicate. This study will include: 1. Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better. 2. Interviews with patients, relatives and focus groups/interviews with staff to find out their views on communication including the use of the new lipreading device. 3. Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health. The study will take place in three critical care units and one acute care unit in Northern Ireland and is expected to last 18 months. The study has been funded by the Public Health Agency Research and Development Division.

NCT ID: NCT05482841 Recruiting - Surgery Clinical Trials

Lung Ultrasound Score After ENT Cancer Surgery

LUSENT
Start date: December 1, 2022
Phase:
Study type: Observational

After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy. The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery. We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

NCT ID: NCT05482022 Recruiting - Tracheostomy Clinical Trials

Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05047432 Recruiting - Tracheostomy Clinical Trials

Concordance of Methods to Select Tracheostomy Tube Size for Adults in Intensive Care

COMETS
Start date: November 19, 2021
Phase:
Study type: Observational

This study is part of a larger PhD project. The aim of the overall project is to provide evidence to help healthcare staff choose the best size tracheostomy breathing tube for patients in intensive care. There are no clear guidelines on how to choose the size of tracheostomy tubes currently. The aim of this part of the project is to compare methods of choosing the size tracheostomy tube for patients. Four methods are based on easily recorded physical characteristics of the participants (sex, height, Body Mass Index and shoulder width). A fifth method is based on measurement of the windpipe (trachea). We will recruit patients and staff at the Royal Free London NHS Foundation Trust. We will measure their height, weight and shoulder width, and record their age and sex. We will use ultrasound to measure each participant's trachea. We will calculate the recommended tube size using the five methods above. We will compare how well the first four methods agree with the method based on measurements of the trachea. The results of this study will inform healthcare staff how well the different ways of choosing the size of tube relate to the fit of a tube in the trachea.

NCT ID: NCT04647968 Recruiting - Tracheostomy Clinical Trials

Primary vs Secondary Closure of Tracheo-cutaneous Fistulas

TRACH
Start date: January 12, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04647786 Recruiting - Tracheostomy Clinical Trials

Safe and Effective Above Cuff Tracheostomy Ventilation

SEACtV
Start date: July 13, 2022
Phase: N/A
Study type: Interventional

A Phase I study of an 'in-house' developed, novel, Class I, prototype medical device to facilitate vocalisation in participants with cuff-inflated tracheostomy tubes. Primary objective: To design and develop a device to deliver Above Cuff Vocalisation (ACV) that is safe, well tolerated and effective at producing a voice in tracheostomised patients in the Intensive Care Unit (ICU). Secondary objective: To evaluate whether more effective delivery of ACV has a significant impact on laryngeal function and recovery following new tracheostomy in ICU patients.

NCT ID: NCT04642703 Recruiting - Covid19 Clinical Trials

Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy

Start date: March 3, 2020
Phase:
Study type: Observational

Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life. The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.