Impact of neuromuscular blockade depth on breathing mechanics in ARDS patients
Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome
This study tests if using a lighter dose of a muscle relaxant can help patients with severe breathing problems breathe better and improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Days to 85 Years |
| Sex | All |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06514209 on ClinicalTrials.gov |
What this trial studies
This study investigates how different depths of neuromuscular blockade affect respiratory mechanics in patients suffering from moderate to severe acute respiratory distress syndrome (ARDS). It aims to determine the optimal level of muscle relaxation using the neuromuscular blocking agent cisatracurium to enhance lung-protective ventilation. The research addresses a critical clinical challenge, as current practices often rely on higher doses of neuromuscular blockers, which may not be necessary. By exploring partial neuromuscular blockade, the study seeks to improve patient outcomes and ventilation strategies in ARDS management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with moderate to severe ARDS requiring neuromuscular blocking agents.
Not a fit: Patients with contraindications to neuromuscular blockers or severe organ dysfunction with expected short-term mortality may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies and better outcomes for patients with ARDS.
How similar studies have performed: While there is ongoing debate regarding the optimal depth of neuromuscular blockade in ARDS, previous studies have suggested that partial blockade may be feasible, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with moderate to severe ARDS requiring the use of NMBAs, as assessed by clinicians (Berlin definition 2012: PaO2/FiO2 \< 150 mmHg, PEEP ≥ 5). 2. Age: 18-85 years. 3. Signed informed consent. Exclusion Criteria: 1. History of allergy to NMBAs. 2. Open chest or abdominal injuries. 3. Patients with pulmonary masses, lung transplantation, or lung resection. 4. Contraindications to esophageal catheter placement. 5. Pregnant patients. 6. Contraindications to TOF measurement (e.g., history of neuromuscular disease, presence of a cardiac pacemaker). 7. Severe dysfunction of other organs with an expected short-term mortality (within 7 days) or palliative care. 8. Previous inclusion in this study.
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital, Affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Lihong Xu
- Email: 220223899@seu.edu.cn
- Phone: +86 18551696812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.