Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respirator… (NCT05465083) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure
Canada20 participantsStarted 2023-02-04
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Group 1: Acute hypoxemic respiratory failure (AHRF)
Inclusion Criteria:
* Age ≥18 years old, and,
* Invasive mechanical ventilation for ≤ 7 days, and,
* Have hypoxemia as defined by one of:
* A PaO2:FiO2 ratio \< 300 and PEEP ≥ 5 cm H2O, or
* SpO2:FiO2 \< 315% on PEEP ≥ 5 cm H2O in absence of an available arterial blood gas, and in the presence of a reliable Sp)2 trace and a SpO2 \< 97%, or
* Are receiving inhaled nitric oxide for acute hypoxemia, or
* Require extracorporeal membrane oxygenation, and,
* Are on controlled mechanical ventilation with no patient-triggered ventilator-delivered breaths with no imminent plan to transition to assisted ventilation within 6 hours, and,
* Are not expected to be liberated from mechanical ventilation within the next 48 hours (from time of enrollment)
Group 2: Pulmonary endarterectomy
Inclusion Criteria:
* Age 18 to 65 years old
* Are listed for pulmonary thromboendarterectomy
* Have pulmonary vascular resistance \< 1000 dynes.sec.cm-5
Group 3: Lung transplant
Inclusion Criteria:
* Age 18 years or older
* Are listed for bilateral lung transplant for a primary indication of idiopathic pulmonary fibrosis with no plan for concomitant transplant of other solid organs
All groups
Exclusion Criteria:
* Pregnant or lactating
* Previously diagnosed neuromuscular disorder or known phrenic nerve injury
* BMI \>70kg/m2
* Implanted electronic cardiac or neurostimulation device in situ
* Contraindications to left internal jugular or subclavi…