Is NCT05440851 recruiting in Lexington, KY?

Yes, NCT05440851 is currently recruiting participants at its Lexington, KY location. This respiratory insufficiency clinical trial is actively enrolling qualified participants.

How do I join the respiratory insufficiency clinical trial in Lexington?

To join this clinical trial in Lexington, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lexington clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Respiratory Insufficiency Clinical Trial in Lexington, KY

About This Respiratory Insufficiency Study in Lexington

PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. A domain may also be a non-interventional study that addresses observational research questions by collecting specific data or outcomes that are not collected as part of other domains. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies and mechanistic pathways within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at regular interim adaptive analyses of the pre-specified outcomes for each intervention in each domain. These adaptive analyses will compute the posterior probabilities of superiority, futility, inferiority, or equivalence for pre-specified comparisons within domains. Each of these potential conclusions will be pre-defined prior to commencing the intervention trial. Decisions about trial results (e.g., concluding superiority or equivalence) will be based on pre-specified threshold values for posterior probability. The primary outcome of interest, the definitions for superiority, futility, etc. (i.e., the magnitude of treatment effect) and the threshold values of posterior probability required to reach conclusions for superiority, futility etc., will vary from intervention to intervention depending on the phase of investigation and the nature of the intervention being evaluated. All of these parameters will be pre-specified as part of the statistical design for each intervention trial. In general, domains will be designed to evaluate treatment effect within four discrete clinical states: non-intubated patients, intubated patients with low respiratory system elastance (\<2.5 cm H2O/(mL/kg)), intubated patients with high respiratory system elastance (≥2.5 cm H2O/(mL/kg)), and patients requiring extracorporeal life support. Where appropriate, the model will specify dynamic borrowing between states to maximize statistical information available for trial conclusions. In this perpetual trial design, different interventions may be added or dropped over time. Where possible, the platform will be embedded within existing data collection repositories to enable greater efficiency in outcome ascertainment. Standardized systems for acquiring both physiological and biological measurements are embedded in the platform, to be acquired at sites with appropriate training, expertise, and facilities to collect those measurements.

Sponsor: University Health Network, Toronto

Who Can Participate

Inclusion Criteria

Acute hypoxemic respiratory failure meeting all of the following criteria;

New or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support

Receiving any of the following types of oxygen or respiratory support for at least 4 hours prior to the time of randomization; supplemental oxygen at 10 L/min or higher, high flow nasal oxygen (at any flow rate), invasive ventilator support, extra-corporeal life support (ECLS), or non-invasive ventilator support

Minimum FiO2 ≥ 0.40 (for venturi mask, high flow nasal cannula, or invasive or non-invasive ventilation) or oxygen flow rate ≥10 L/min on face mask for at least 4 hours at the time of evaluation for eligibility unless already on extra-corporeal life support

Age ≥ 18 years

Hypoxemia not primarily attributable to acute heart failure, fluid overload, or pulmonary embolism (PE) PRACTICAL Platform

Exclusion Criteria

Extubation is planned or anticipated on the day of screening

ICU discharged is planned or anticipated on the day of screening

If the patient is moribund and deemed unlikely to survive 24 hours (as determined by the clinical team)

If the patient is being transitioned to a fully palliative philosophy of care EXPAND-ECLS Domain Inclusion Criteria:

Receiving invasive Endotracheal mechanical ventilation for ≤ 72 hours.5 days

Early Moderate-severe hypoxemic respiratory failure with a PaO2/FiO2≤150200 mmHg for at least 6 hours EXPAND-ECLS Domain Exclusion Criteria:

Patients over 70 years of age.

Currently receiving any form of ECLS (e.g., Venovenous, venoarterial, or hybrid configuration).

Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting.

Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BiPAP used solely for sleep-disordered breathing.

Actual body weight exceeding 1 kg per centimeter of height.

More than 48 hours have passed since meeting inclusion criteria.

Severe hypoxemia with PaO2/FiO2 \< 80mmHg for \> 6 hours at time of screening.

Severe hypercapnic respiratory failure with pH \< 7.25 and PaCO2 \> 60 mmHg for \> 6 hours at time of screening.

Expected mechanical ventilation duration \< 48 hours at time of screening.

Confirmed diffuse alveolar hemorrhage from vasculitis.

Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis).

Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia

Neurologic conditions at risk for or undergoing treatment for intracranial hypertension

Underlying illness with life expectancy \< 1 year

Pregnancy (due to unknown effects of PaCO2 changes on placental blood flow)

Respiratory failure known or suspected to be caused by COVID-19. IMV Domain Inclusion Criteria:

Intubated patients, not on ECLS, with low normalized respiratory elastance (\<2.5 cm H2O/(ml/kg predicted body weight)) at the time of eligibility assessment OR

Intubated patients, not on ECLS, with high normalized respiratory system elastance (≥2.5 cm H2O/(ml/kg predicted body weight)) at the time of eligibility assessment OR

FOR STUDY SITES PARTICIPATING IN THE LDPVS INTERVENTION: Patient is on ECLS at the time of eligibility assessment. Note: Patients in this state are only eligible for the LPV or LDPVS intervention

FOR STUDY SITES PARTICPATING IN THE EIT INTERVENTION: PaO2/FiO2 (if available) \< 200 mm Hg at randomization. If PaO2/FiO2 has not been measured, SpO2 = 97% on FiO2 =60%. IMV Domain Exclusion Criteria:

PaO2/FiO2 \>300 mm Hg or (S/F \>250, if PaO2/FiO2 has not been measured) at the time of randomization

Chronic hypercapnic respiratory failure defined as PaCO2\>60mmHg in the outpatient setting

Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not including nocturnal CPAP applied by nasal or face mask or home tracheotomy if not ventilated

Severe hypoxemia with PaO2/FiO2\<80mmHg for \>6 consecutive hours at the time of randomization

Severe hypercapnic respiratory failure with pH\<7.25 and PaCO2\>60mmHg for \>6 consecutive hours at the time of randomization

Anticipated duration of mechanical ventilation is \<48 hours from the time of screening

Duration of mechanical ventilation during current ICU admission is \>72 hours

Previously diagnosed neuromuscular disorder

Current diagnosis of severe acute brain injury (e.g. ischemic or hemorrhagic stroke, traumatic brain injury) with Glasgow Coma Scale ≤ 8

Baseline weight prior to or at hospital admission less than 35 kilograms

Receiving extracorporeal life support without continuous invasive mechanical ventilatory support CORT-E2 Domain Early Cohort Inclusion Criteria

Within 72 hours of admission to an ICU

New unilateral or bilateral airspace disease CORT-E2 Domain Early Domain Exclusion Criteria

Receiving only low flow oxygen therapy less than or equal to 15L/min

Corticosteroid use during the 14 days prior to screening

Existing indication for corticosteroids

High suspicion for/or confirmed COVID infection

Acute traumatic brain injury during the index hospital admission

Allergy to dexamethasone CORT-E2 Domain Extended Cohort Inclusion Criteria

Are admitted to an ICU

Have already received 10 days of corticosteroid specifically for acute respiratory failure, this will include patients: (a) randomized to corticosteroid arm in Early Cohort, (b) patients with COVID receiving corticosteroids as standard of care , (c) and others who have received corticosteroids for AHRF

Ongoing AHRF requiring HFNC, NIV (continuous positive airway pressure \[CPAP\] or bilevel) or invasive ventilation CORT-E2 Domain Extended Cohort Exclusion Criteria

An alternate indication for ongoing corticosteroids

Acute traumatic brain injury this hospital admission FLUDRO Domain Inclusion Criteria 1. Within 72 hours of admission to an ICU FLUDRO Domain Exclusion Criteria

Known hypersensitivity to fludrocortisone

An inability to receive fludrocortisone due to lack of enteral access

An indication to prescribe fludrocortisone for a reason that is unrelated to a current episode of pneumonia or acute respiratory failure, such as Addison's disease

Belief of the treating clinical team that study participation would not be in the best interest of the patient FAST-3 Domain Inclusion Criteria (must meet all 3 of the following)

Patient is in a PRACTICAL eligible platform state and requires advanced respiratory support (ARS) defined as one of the following: a. Invasive mechanical ventilation with FiO2 \> 40% b. Non-Invasive Ventilation (\> 4 hours consecutively with FiO2 \> 40%) defined as: i. CPAP or BiPAP (any settings or interface) ii. HFNC (flow \> 40 liter per minute)

PaO2/FiO2 \< 300 mm Hg or SpO2/FiO2 \< 315 (if PaO2/FiO2 unavailable due to lack of arterial blood gas at the time of screening). For SpO2/FiO2, criteria are SpO2 ≤ 97% on FiO2 ≥ 40% on both of the 2 hours immediately preceding eligibility assessment. If an arterial blood gas can be obtained, then a PaO2/FiO2 ratio is preferable.

Patient commenced advanced respiratory support \< 48 hours prior to randomization. FAST-3 Domain Exclusion Criteria

Patient commenced advanced respiratory support \> 48 hours to time of randomization.

Known history of severe chronic pulmonary disease e.g., pre-infection requirement for home oxygen therapy or presence of chronic hypercapnia (PaCO2 \> 60 mmHg); mild - moderate disease is still eligible in the absence of chronic hypercapnia or need for chronic oxygen therapy.

Currently enrolled in another trial studying investigational anti-inflammatory therapy, excluding established treatments used in clinical practice such as corticosteroids.

Known allergy to furosemide or sulfonamide drugs. If the patient is allergic to sulfonamide drugs but has received in the past or is currently receiving furosemide without incident, they can be enrolled since cross-reactivity between furosemide and sulfonamide agents is rare. ESCAPE Domain Inclusion Criteria

Patients with severe AHRF who have an underlying immunocompromised condition

Within 48 hours of fulfilling the AHRF inclusion criteria as well as PaO2/FiO2 \<300 or a SaO2/FiO2 \< 315 on non-invasive respiratory support (venturi mask, non-invasive ventilation or high flow nasal oxygen as per the FiO2 requirements above) or invasive ventilation. Patients may be enrolled from the wards or ICU. Immunocompromised patients include:

Any patients requiring long term (\>30 days) corticosteroids (\>20 mg/day),

Any patients receiving non-corticosteroid immunosuppressive medications within the prior 3 months,

Acquired or inherited immunodeficiency syndrome,

Recipients of solid organ transplant,

Active hematologic malignancy (diagnosis or receiving treatment within prior 6 months),

Active solid tumor (diagnosis or receiving treatment within the prior 6 months) or

Any patients who have undergone allogeneic or autologous hematopoietic cell transplant in the prior 6 months (HCT). ESCAPE Domain Exclusion Criteria

Patients whom are deemed palliative. WAVEFORM Domain Inclusion Criteria 1\. Patient is intubated at the time of eligibility assessment. WAVEFORM Domain Exclusion Criteria

PaO2/FiO2 \>300 mm Hg or (S/F \>250, if PaO2/FiO2 has not been measured) at the time of eligibility assessment.

Duration of mechanical ventilation during current ICU admission is ≥72 hours.

Receiving ECLS without continuous invasive mechanical ventilatory support. IMV-ECLS Domain Inclusion Criteria 1\. Patients with AHRF (as defined in platform inclusion criteria #1 above) who have been consented for cannulation for VV-ECLS or who have been initiated on VV-ECLS within 6 hours at the time of randomization IMV-ECLS Domain Exclusion Criteria 1. Patients receiving ECLS for the primary intention of extracorporeal CO2 removal 2. Patients expected to be liberated from ECLS within \<24 hours 3. History of recent pneumothorax or pneumomediastinum (\<3 months at the time of eligibility assessment/randomization) 4. Patients receiving ECLS for the primary intention of bridge to lung transplantation (at the time of eligibility assessment/randomization) IMPROV Domain Inclusion Criteria

Patients receiving invasive mechanical ventilation for AHRF as defined by the PRACTICAL platform trial criteria above.

Within 7 calendar days of intubation IMPROV Domain Exclusion Criteria

Patient is expected to be liberated from mechanical ventilation within 24 hours

Known or suspected chronic hypercapnic respiratory failure defined as PaCO2\>60mmHg in the outpatient setting

Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not including nocturnal CPAP applied by nasal or face mask or home tracheotomy if not ventilated

Known pneumothorax or pneumomediastinum without chest tube placement sustained during current ICU admission\

(re-confirm immediately prior to randomization)

Patient is admitted primarily for acute brain injury (stroke, traumatic brain injury, etc.)

Previously diagnosed chronic neuromuscular disorder

Patient has an implantable cardiac defibrillator or pacemaker

Planned to be transferred to another hospital before ICU discharge

Already receiving a regimen of inspiratory muscle training using external resistive device or diaphragm neurostimulation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lexington?

Yes, this clinical trial (NCT05440851) has an active research site in Lexington, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Respiratory Insufficiency Treatment Options in Lexington, KY

If you're searching for respiratory insufficiency treatment options in Lexington, KY, this clinical trial (NCT05440851) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lexington research site is actively enrolling participants for this clinical trial. You'll receive care from experienced respiratory insufficiency specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all respiratory insufficiency clinical trials near you to find additional studies recruiting in your area.

Respiratory Insufficiency Clinical Trial in Lexington, KY

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