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Respiratory Failure clinical trials

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NCT ID: NCT04644276 Terminated - Covid19 Clinical Trials

Mask Adhesive Institutional Study

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

To reduce interface leak and aerosol spread, Philips has developed an accessory to non-invasive ventilation(NIV) masks to be used with the Philips AF531 and the PerformaTrak mask on respiratory failure patients. For the purposes of capturing initial mask leak and safety data, this trial will enroll patients treated with NIV in an institutional setting (i.e., sleep lab).

NCT ID: NCT04588792 Terminated - Covid19 Clinical Trials

Furosemide as Supportive Therapy for COVID-19 Respiratory Failure

FaST-1
Start date: April 16, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study will study the utility of nebulized furosemide for pulmonary inflammation in Intubated, mechanically ventilated Patients with COVID-19.

NCT ID: NCT04433546 Terminated - Pneumonia Clinical Trials

Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).

VANGARD
Start date: July 15, 2020
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.

NCT ID: NCT04368000 Terminated - COVID-19 Clinical Trials

Prone Positioning in Awake Patients With COVID-19 Requiring Hospitalization

PAPR
Start date: April 29, 2020
Phase: N/A
Study type: Interventional

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

NCT ID: NCT04339816 Terminated - COVID-19 Clinical Trials

Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial

AZIQUINE-ICU
Start date: May 13, 2020
Phase: Phase 3
Study type: Interventional

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT ID: NCT04269681 Terminated - Respiratory Failure Clinical Trials

RENOVATE Palliative: HFNC vs. Standard Respiratory Support in Patients With Do-Not-Intubate Order and ARF

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Randomized clinical trial in which the main objective is to compare High Flow Nasal Cannula (HFNC) versus the standard respiratory care in the alleviation of dyspnea perception in patients with do-not-intubate (DNI) order. This is a pragmatic study that will take place in 10 Brazilians ICU facilities which are already participating in the main study RENOVATE NCT03643939.

NCT ID: NCT04085679 Terminated - Infection Clinical Trials

Multidisciplinary Mobile Unit for Preventing Hospitalization of Nursing Home Residents

MMU-1
Start date: January 15, 2020
Phase:
Study type: Observational

Elderly patients residing in nursing homes are particularly at risk of experiencing urgent medical problems needing admission to the Emergency Department (ED). This circumstance contributes to ED overcrowding, increases the risk of ward admission of elderly patients, and puts them at an even higher risk of hospitalization-related adverse events. The study hypothesis is that a complex intervention, delivered directly in nursing homes by hospital physicians in case of urgent medical problems, would contribute to reduce hospitalization of older nursing home residents. The intervention consists in a hospital-based "multidisciplinary mobile unit" (MMU), composed of a hospital specialist and a resident in emergency-urgency medicine who are coordinated by a senior physician serving as "flow manager". The team is active on work days, 8 am to 6 pm, and is activated by general practitioners of nursing homes, in case of urgent medical needs of one of the residents. The activation is made by a phone call to the "flow manager", who triages the clinical needs of the case. The output of the phone consultation may include therapeutic advice provided by phone, immediate on-site visit by the MMU team (specialist and resident), scheduled visit by the MMU team, or direct admission to the hospital unit where MMU is based, avoiding ED visits. The MMU team is provided with a portable ultrasound system, an essential set of drugs and medical devices useful in a urgency setting (central venous lines, nasogastric tubes, rectal tubes, bladder catheters). During on-site visits, the MMU team performs diagnosis, stabilization and therapeutic advice, with the mission of avoiding ED visits and hospital admissions whenever possible. The MMU intervention is already active in two nursing homes, since December 2018. The aim of this prospective, pragmatic, multicenter, quasi-experimental study (sequential design with two cohorts) is to test the effects of the implementation of the MMU care model in terms of reduction of unplanned hospitalization rates (primary outcomes), mortality, health service use and costs (secondary outcomes). Two nursing homes (i.e., the ones who already benefit from the intervention) will serve as study group, and two nursing homes with similar geographical location will serve as control group. All residents of the participating nursing homes will be eligible for study inclusion. The study will last for 18 months, and a number of 338 residents is planned for inclusion.

NCT ID: NCT03993002 Terminated - Respiratory Failure Clinical Trials

DAMP-Mediated Innate Immune Failure and Pneumonia After Trauma - the Harvard-Longwood (HALO) Campus Area Consortium

HALO
Start date: November 15, 2019
Phase: N/A
Study type: Interventional

The mortality burden of trauma in the United States is substantial, and is currently the leading cause of death in warfare and in civilians below age 45. Infection and sepsis are leading causes of morbidity and death in early survivors. Pneumonia (PNA) occurs in 17-36% of ventilated trauma patients; far more than non-trauma patients. The long held dogmatic notion of a mechanical predisposition to development of pneumonia in trauma has lacked robust support. However, there is evidence of the innate immune response to injury plays a major role in increasing susceptibility to infection. This application is for support of a Focused Program Award addressing the role that "danger signaling" due to "danger associated molecular patterns" (or DAMPs) derived from somatic tissue injuries play in altering innate immune signaling in the lung in ways that predisposes to PNA. This innate immune response plays a pivotal role in the development and progression of lung inflammation. The organization of the Focused Program Award is into six Projects with collaborators from the Departments of Surgery, Medicine and Anesthesiology at Beth Israel Deaconess Medical Center; the Department of Surgery at Brigham and Women's Hospital and the Departments of Biology and Biological Engineering at Massachusetts Institute of Technology. The human subjects interaction portion of this project is covered in the Human Subjects & Samples Project of the Award, although the information and tissues obtained from this Project will be shared with the other Projects, and the activities planned for those Projects are outlined in this application.

NCT ID: NCT03962725 Terminated - Respiratory Failure Clinical Trials

Avoiding Neuromuscular Blockers to Reduce Complications

Start date: August 7, 2019
Phase: Phase 4
Study type: Interventional

The goal of this study to evaluate whether eliminating the use of non-depolarizing neuromuscular blocking agents (NMBA) for maintenance of general anesthesia reduces postoperative pulmonary complications in higher risk patients.

NCT ID: NCT03862027 Terminated - Respiratory Failure Clinical Trials

Safety of Optimal PEEP in NSICU Patients

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The investigators aim to demonstrate that use of transpulmonary pressure to guide PEEP management is safe in patients with possible elevations of intracranial pressure.