Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05465083

Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure — STIMULUS  

Acute Hypoxemic Respiratory Failure Clinical Trial

Official title:
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure: The STIMULUS I Clinical Trial

Clinical Trial Summary

This is a single-center proof-of-concept clinical trial designed to establish the feasibility of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the first 24 hours and for up to seven days of mechanical ventilation in patients who are likely to require more than 48 hours of invasive mechanical ventilation.

Clinical Trial Description

The diaphragm is the main muscle of breathing and for most of us therefore is continuously being used (and hence exercised) when in health. When people are unwell with severe breathing difficulties to the degree that their lungs are needing a lot of support from a breathing machine (ventilator) in the intensive care unit (ICU), or are recovering from major lung/chest surgery on a ventilator in ICU, the diaphragm can quickly start to weaken from its inactivity. This means that even when starting to recover from the underlying medical problem, or from the surgery itself, the diaphragm may be unable perform well enough to take over the work of breathing once again. This can lead to not only longer times on the ventilator (time to gradually rebuild diaphragm strength by rehabilitation and physiotherapy) but also therefore longer times in ICU and in hospital with the risk of complications that can be associated with this. Stimulating the diaphragm by use of a pacemaker (electrical stimulation) is an established treatment for a number of patients with certain types of long-term breathing problems. These pacemakers are permanent and are inserted by invasive surgical methods. More recently however, there have also been a number of studies looking to see if it is possible to safely, temporarily and less invasively stimulate the diaphragm of patients who only have temporary diaphragm inactivity. This has been done either during surgery or during their intensive care stay. A number of methods of temporarily stimulating the diaphragm have been looked at, but the simplest has been to integrate the function of stimulating the nerves (that ultimately control the diaphragm) with a catheter that is frequently placed into a vein in the neck to enable delivery of medications during surgery and in ICU. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05465083
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase N/A
Start date February 4, 2023
Completion date November 10, 2023
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06007495 - Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout. N/A
Completed NCT05060926 - Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning
Recruiting NCT05203536 - Respiratory Mechanics Assessment During Assisted Mechanical Ventilation
Completed NCT04570384 - Intravenous L-Citrulline Influence on the Need for Invasive Mechanical Ventilation for Acute Hypoxemic Respiratory Failure in Patients With COVID-19 Phase 2
Not yet recruiting NCT05499039 - High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure. N/A
Completed NCT04568642 - Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2 N/A
Completed NCT03653806 - Automated Analysis of EIT Data for PEEP Setting
Completed NCT01747109 - Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study N/A
Terminated NCT04632043 - Early Versus Delayed Intubation of Patients With COVID-19 N/A
Completed NCT04581811 - Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS) N/A
Not yet recruiting NCT06064409 - Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study
Completed NCT03133520 - Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure N/A
Recruiting NCT04997265 - Strategies for Anticoagulation During Venovenous ECMO N/A
Completed NCT05083130 - Awake Prone Positioning in Moderate to Severe COVID-19 N/A
Active, not recruiting NCT06374589 - Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) N/A
Active, not recruiting NCT06333002 - Machine Learning Model to Predict Outcome and Duration of Mechanical Ventilation in Acute Hypoxemic Respiratory Failure
Recruiting NCT05078034 - HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT N/A
Recruiting NCT03513809 - Inflammation and Distribution of Pulmonary Ventilation Before and After Tracheal Intubation in ARDS Patients
Terminated NCT04395807 - Helmet CPAP Versus HFNC in COVID-19 N/A
Completed NCT00578734 - Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old Phase 2