Shenfu Injection Trial Puts Diaphragm Recovery at the Center of Ventilator Weaning
A new multicenter randomized trial is taking aim at one of intensive care medicine’s most stubborn problems: ventilator dependence. In critically ill adults who require invasive mechanical ventilation, the study will test whether Shenfu Injection can prevent or treat ventilator-induced diaphragm dysfunction and increase the chance of successful liberation from the ventilator.
The clinical question is straightforward, but the biology is not. When mechanical ventilation stretches on, the diaphragm can weaken quickly, and that weakness can become part of the reason a patient cannot come off support. By pairing drug administration with daily bedside ultrasonography, investigators are trying to capture both the functional and clinical sides of recovery in real time.
Two Parallel Paths: Prevention and Treatment
This is a randomized, open-label, parallel-group study with two components. One branch focuses on prevention in patients who are still receiving mechanical ventilation but have not yet declared themselves ventilator dependent. The other branch enrolls patients with established ventilator dependence and asks whether the same intervention can assist active weaning.
In both components, eligible participants will receive either Shenfu Injection or a control treatment consisting of 5% glucose injection in addition to standard clinical care. The trial uses a multicenter design and plans to enroll 400 participants, with study start recorded as 2026-04-01 and estimated completion set for 2027-08-31.
The prevention arm begins after more than 24 hours of mechanical ventilation. Shenfu Injection is given intravenously twice daily, one ampoule per administration, until successful ventilator weaning. Participants receiving mechanical ventilation for less than 70 hours are excluded from that portion of the protocol.
The treatment arm is more prescriptive. Patients with established ventilator dependence will receive Shenfu Injection twice daily for 10 consecutive days, and ventilator-weaning training begins on Day 3. Weaning time is then increased progressively by 3 hours per day until the participant remains successfully liberated from mechanical ventilation for more than 48 hours.
A placebo comparison matters here because ventilator weaning is heavily influenced by concurrent ICU care, sedation practices, respiratory muscle conditioning, and the pace of recovery from the underlying illness. A matching glucose control makes the treatment effect easier to interpret than an unblinded supportive-care study would.
Diaphragm Ultrasound Will Track the Mechanistic Signal
The protocol makes diaphragm monitoring central rather than optional. Daily bedside ultrasonography will assess diaphragm excursion and diaphragm thickness, giving the study a physiologic readout that can move alongside the clinical endpoint.
That design is important because ventilator dependence is not just a yes-or-no bedside label. It often reflects the mismatch between respiratory demand and the ability of the diaphragm to generate adequate force. If Shenfu Injection truly improves the path toward weaning, the change may appear first in diaphragm mechanics before it becomes obvious in the chart.
Successful ventilator weaning is the primary endpoint. The study defines it as liberation from invasive mechanical ventilation followed by at least 48 consecutive hours without reinstitution of invasive ventilation. The outcome will be measured from randomization through Day 10 after initiation of the study intervention.
Secondary outcomes include time to successful ventilator weaning, the need for resumption of mechanical ventilation within 48 hours after initial weaning, and the diaphragm measurements tracked by ultrasound. Those measures should help separate a brief extubation success from a more durable recovery of respiratory muscle function.
Why This Trial Is Narrowly Defined
Eligibility criteria are tight. Participants must be critically ill adults requiring mechanical ventilation and be older than 18 years but younger than 75 years. The protocol excludes patients with a history of hypertension or diabetes mellitus and excludes those with a history of allergy to traditional Chinese medicine injections.
The exclusion list is also clinically revealing. Motor neuron disease, Guillain-Barré syndrome, myasthenia gravis, mitochondrial myopathy, severe thoracic deformity, and high cervical spinal cord injury or myelitis are all left out of the study population. Each of these conditions can independently impair respiratory muscle performance or complicate interpretation of diaphragm weakness, making them important confounders in a trial centered on weaning.
The age range listed elsewhere in the record spans 19 to 75 years, and no healthy volunteers are being enrolled. The study is running at The Fourth Affiliated Hospital of Zhejiang University School of Medicine in Yiwu, Zhejiang, China, with Min Li listed as the study contact.
A Test of Respiratory Muscle Support, Not Just Drug Exposure
Shenfu Injection is being tested in a setting where small physiologic gains can matter. If a treatment improves diaphragm excursion, preserves diaphragm thickness, or shortens the interval to sustained ventilator independence, the bedside consequences could be immediate: fewer days on positive-pressure support, less exposure to ventilator-associated complications, and a more efficient path out of the ICU.
The trial’s open-label design leaves room for bias in a domain where clinician judgment influences readiness for extubation and the pace of weaning. Even so, the use of objective ultrasound measures and a clearly defined 48-hour durability threshold should help stabilize the analysis.
At this stage, the study is a protocol rather than a results report. No efficacy or safety outcomes have been posted, and the final answer will depend on whether the intervention can improve ventilator liberation under real ICU conditions rather than merely in theory. The most consequential readout will be whether the diaphragm findings and the clinical weaning endpoint move in the same direction once the cohort is complete.