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Tracheostomy clinical trials

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NCT ID: NCT04941456 Enrolling by invitation - Tracheostomy Clinical Trials

Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?

Start date: July 29, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the use of the Passy-Muir Valve improves endurance for patients in the Long Term Acute Care setting as measured with the Six- Minute Walk Test.

NCT ID: NCT04872881 Not yet recruiting - Clinical trials for Intubation, Intratracheal

Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

Tracheostomy is a vital procedure in the ICU to maintain the airway and prevent complications that may occur due to intubation. It helps reduce the dead space volume, airway resistance and provides comfort to the patients during the weaning from mechanical ventilation. Two methods are widely used in Percutaneous Dilatational Tracheostomy (PDT): The multiple dilation method (Ciaglia) and the Griggs method.Griggs method will be used in the study. The Griggs Method: A 10-15 millimeter skin incision is made between the level of the second-third tracheal rings. The location of the needle is confirmed by entering the trachea with an injector filled with 2-3 mL saline from the midline and aspirating air. A J-tipped guidewire is advanced through the needle and the needle is removed. A special forceps with a channel at the tip, through which the guidewire can pass is used in this method. The forceps advanced through the guidewire and then subcutaneous tissues and trachea are dilated in one or two steps. When the stoma is large enough to insert the cannula, it is placed in the trachea and fixed. Patients who will undergo tracheostomy in the ICU will be included in the study and randomly assigned into two groups. Two different methods, endotracheal tube (ET) or laryngeal mask (LMA), will be used during the tracheostomy for airway management. In both methods, fiberoptic bronchoscopy will assist the procedure. Researchers aim to compare the two airway management methods in terms of complications, procedure time, and the number of staff needed.

NCT ID: NCT04841889 Completed - Weaning Failure Clinical Trials

Determinants of Successful Decannulation in Difficult-to-wean Patients

DESCATRON
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The factors of success of decannulation are not well known in the literature and the decision to decannulate is mainly based on clinical judgment. The failure rate of decannulation is between 2 and 25% with a poor prognosis in case of failure. The objective of this study is to determine the factors associated with successful tracheostomy removal in patients hospitalized in a respiratory weaning unit. The secondary objectives are to evaluate in tracheostomized and hospitalized patients in weaning unit: - The prevalence of successful tracheostomy removal; - The prevalence of successful weaning from mechanical ventilation; - Factors associated with successful weaning from mechanical ventilation; - Demographic characteristics of these patients at admission; - Ventilatory characteristics of these patients at admission; - Biological characteristics of these patients at admission; This is a prospective, single-centre, interventional cohort study with an expected duration of 2 years. All patients admitted to the respiratory weaning unit in the Forcilles' hospital, with a tracheostomy and an expected duration of mechanical ventilation > 48 hours will be consecutively included. All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors.

NCT ID: NCT04668742 Completed - Clinical trials for Mechanical Ventilation Complication

Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients

DYNAtraq
Start date: November 25, 2019
Phase: N/A
Study type: Interventional

Although tracheostomy is a common technique in Intensive Care Units (ICU), its complications can be frequent (between 5% to 40%). Inadequate fixation could favor decannulation, as well as incorrect alignment of the tracheostomy with respect to the tracheal axis could favor the appearance of tissue alterations such as ulcers, bleeding or fistulas, as well as obstruction of the ventilatory obstruction. Having a device that is effective in fixation and alignment could help in reducing tracheostomy complications, so this study aims to evaluate the effect and safety of a fixation device for tracheostomy through a randomized clinical trial.

NCT ID: NCT04652401 Completed - Quality of Life Clinical Trials

Quality of Life in Ventilator-dependant Neuromuscular Patients

EqualVENT
Start date: December 2, 2020
Phase:
Study type: Observational

This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).

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.

NCT ID: NCT04457427 Withdrawn - Clinical trials for Ventilator-Induced Lung Injury

Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Start date: December 2016
Phase: N/A
Study type: Interventional

This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.

NCT ID: NCT04447638 Completed - Tracheostomy Clinical Trials

Percutaneous Tracheostomy With COVID-19

Start date: March 20, 2020
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.