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Respiratory Insufficiency clinical trials

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NCT ID: NCT06064409 Not yet recruiting - Respiratory Failure Clinical Trials

Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study

Start date: November 1, 2023
Phase:
Study type: Observational

This study targets adult patients treated with high flow nasal cannula (HFNC) at emergency department (ED) of Severance hospital, Yonsei university. Patients with acute hypoxic respiratory failure presenting to the ED receive conventional oxygen therapy as initial treatment unless immediate endotracheal intubation is required. Partial rebreathing oxygen masks are mainly applied at first. If the patient's condition does not improve despite such treatment, the patient receives HFNC or endotracheal intubation. However, possible treatment range have not been studied, especially in ED. Decisions are made based on the personal experience of the medical staff in charge. Applying HFNC to patients who eventually fail can lead to delayed intubation and increased mortality. Failure prediction models such as ROX index and HACOR score have been developed due to such reasons. However, such models are mostly based on intensive care unit studies and after application of HFNC. Therefore, failure prediction model at the time before application of HFNC and efficacy of existing models in ED are necessary. This study is a prospective observational study and follows the standard treatment guidelines applied to the patient and the judgment of the attending physician during the patient's treatment process. Immediately before applying HFNC, the patient's respiratory rate, pulse rate, blood pressure, SpO₂, PaO₂, PaCO₂, GCS score are determined, and FiO₂ is measured above upper lips using oxygen analyzer(MaxO2+AE, Maxtec, USA). From these data, ROX index (SF ratio/respiratory rate), ROX-HR (ROX index/pulse rate), POX index (PF ratio/respiratory rate), POX-HR (POX index/pulse rate), and HACOR score (Heart Rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) are calculated. The settings (flow rate, FiO₂, temperature) at the time of HFNC application are also measured. The same indices and HFNC settings are checked 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours after applying HFNC. Modified Borg score and comfort scale using 5-point Likert scale are additionally determined at 30 minutes for patient's comfort. Primary outcome is HFNC failure at 28 days, defined by endotracheal intubation. Other outcomes include intubation in ED and mortality at 28 and 90 days collected through phone interview. The receiver operating curve for ROX index, HACOR score, ROX-HR, and POX-HR at baseline, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 12 hours are drawn for the outcomes. The area under the curve of the above indices are compared and cutoff values are chosen with maximum value of index J by the Youden's Index. A binary variable is created based on the cutoff values and multivariable logistic regression analyses are performed. Cutoff values for maximum specificity are also invested suggesting the lower limit of the indicator to which HFNC can be applied.

NCT ID: NCT06029699 Not yet recruiting - Respiratory Failure Clinical Trials

High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning

NCT ID: NCT06007495 Not yet recruiting - Clinical trials for Acute Hypoxemic Respiratory Failure

Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.

Start date: September 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and acute hypoxemic, respiratory failure. The main questions it aims to answer are: - Does a mask with expiratory washout improve minute ventilation in patients using non-invasive ventilation compared with a conventional single-limb NIV mask - How does a mask with expiratory washout affect respiratory variables compared with a dual-limb NIV mask. Participants already prescribed NIV will undergo 3 arms of the investigation in a randomized order: - Single-limb NIV with investigation mask (with expiratory washout) - Single-limb NIV with conventional mask - Dual-limb NIV with conventional mask

NCT ID: NCT06002841 Not yet recruiting - Pneumonia Clinical Trials

Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure

Start date: February 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, randomized, double-blind, placebo-controlled clinical trial that will evaluate the safety and potential efficacy of therapy with extracellular vesicles (EVs) obtained from mesenchymal stromal cells (MSCs), patients with moderate to severe acute respiratory distress syndrome due to COVID-19 or other etiology. Participants will be allocated to receive EVs obtained from MSCs or placebo (equal volume of Plasma-Lyte A). Blinding will cover the participants, the multidisciplinary intensive care team and the investigators.

NCT ID: NCT05964244 Not yet recruiting - Clinical trials for Noninvasive Ventilation

Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure

Start date: November 2023
Phase: N/A
Study type: Interventional

This study will determine if NIV using the Vela investigational mask with expiratory washout of the upper airway more effectively reduces respiratory rate in acute patients with hypercapnic respiratory failure. Patients admitted to hospital with acute respiratory failure (ARF) will be assessed for hypercapnic ARF by normal hospital protocols. Patients requiring noninvasive ventilation (NIV) will be set up on NIV as prescribed per standard of care. Enrollment onto the investigation will occur after the patient has been allowed to stabilize on NIV . Patients that meet the inclusion/exclusion criteria will be approached for consent. Investigation participants will receive two masks in random order; 1. NIV for one hour with the investigational mask (Vela) 2. NIV for one hour with the standard mask (Nivairo). Participants will have their physiological respiratory parameters recorded.

NCT ID: NCT05958862 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial

Start date: July 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (PEEP; a standard of care ventilator parameter). The main question it aims to answer is: The time to stability of driving pressure after a change in PEEP is made Type of study: observational study participant population/health conditions Participants will undergo a "best PEEP trial" which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. This involves changing the patient's PEEP and looking for response in driving pressure. This will be done in a more protocolized format and data will be collected.

NCT ID: NCT05955534 Not yet recruiting - Respiratory Failure Clinical Trials

Concomitant Bedside Percutaneous Tracheostomy and Ultrasound Gastrostomy

TPUG
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this research study is to assess the FDA approved technique for inserting a feeding tube (gastrostomy) along with a breathing tube (tracheostomy) for patients that cannot breathe or eat on their own in the ICU (Intensive Care Unit). All subjects in the study will receive a tracheostomy, but each patient will be randomly assigned a common method for gastrostomy placement. The placement of the tube and tracheostomy will occur as part of normal clinical practice. Researchers will compare subjects in the control group and the intervention group to evaluate the benefits of performing a tracheostomy and gastrostomy tube at the same time. Researchers will also evaluate the likelihood of the PUG procedure decreasing a patient's length of stay in the ICU.

NCT ID: NCT05906030 Not yet recruiting - Pneumonia Clinical Trials

Diaphragm Dysfunction and Ultrasound Perioperatively

DiaphPeriop
Start date: September 1, 2023
Phase:
Study type: Observational

This study aims at determining whether diaphragm ultrasound examining diaphragm thickening fraction, excursion and density before and after surgery can predict respiratory complications in the postoperative period. Patients scheduled for major elective abdominal, pelvic or vascular surgery will be included in the study and diaphragm ultrasound is performed before surgery and after surgery in the postoperative ward. Physiological parameters, laboratory parameters, data on surgery and anesthesia and comorbidities will be registered. Complications such as pneumonia, desaturation, need for intubation and other respiratory events up to 30 days will be registered and later correlated with the diaphragm measurements.

NCT ID: NCT05869045 Not yet recruiting - Respiratory Failure Clinical Trials

POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.

NCT ID: NCT05864898 Not yet recruiting - Clinical trials for Acute Respiratory Failure Patients on NIV and HFNC

Predictors of Failure of Non-invasive Ventilation and High Flow Nasal Cannula

Start date: July 1, 2023
Phase:
Study type: Observational

Comparison between some predictors of failure of non-invasive ventilation and high flow nasal cannula.