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Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome

Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06514209
Acronym
ARDS
Enrollment
20
Registered
2024-07-23
Start date
2024-06-28
Completion date
2025-06-30
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Lung Protective Ventilation

Keywords

ARDS, lung protective ventilation, neuromuscular blockade, respiratory mechanics

Brief summary

Acute respiratory distress syndrome (ARDS) is characterized by acute diffuse alveolar injury caused by a variety of pulmonary and extrapulmonary factors, leading to refractory hypoxemia. It has high incidence and mortality rates. Neuromuscular blocking agents (NMBAs) play a crucial role as adjunctive therapy for ARDS, aiding in lung-protective ventilation by inhibiting excessive spontaneous breathing, improving patient-ventilator synchrony, and reducing barotrauma. Determining the appropriate depth of muscle relaxation in moderate to severe ARDS patients receiving NMBAs remains a clinical challenge. Research has shown that partial neuromuscular blockade is feasible in certain ARDS patients. However, large randomized controlled trials (RCTs) and clinical practices often use higher doses of NMBAs to ensure complete cessation of spontaneous breathing. This indicates an ongoing debate regarding the optimal depth of neuromuscular blockade necessary for lung-protective ventilation in ARDS patients. It also raises the question of whether the optimal depth of neuromuscular blockade varies among patients with different severities of ARDS. This study aims to investigate changes in respiratory mechanics and other physiological parameters in moderate to severe ARDS patients under different depths of neuromuscular blockade. The investigators will evaluate the impact of targeted neuromuscular blockade depth on lung protection in these patients.

Interventions

DRUGcisatracurium

The initial bolus dose of cisatracurium injection is 0.05-0.1mg/kg, followed by a continuous infusion of 1ug/kg/min of cisatracurium, with data on vital signs, respiratory mechanics, TOF response, etc. recorded after a 15-minute wait. The maintenance infusion dose of cisatracurium is then gradually increased in a gradient of 0.5ug/kg/min, with data collection after a 15-minute wait after each increase. If the patient's spontaneous breathing completely disappears, the infusion dose of cisatracurium will no longer be increased, and the titration will end.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Days to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
transpulmonary pressure (PL)At baseline and 15 minutes after each adjustment of the cisatracurium dose.

Secondary

MeasureTime frame
esophageal pressure swing(∆Pes)At baseline and 15 minutes after each adjustment of the cisatracurium dose.
train train of four count (TOF-count)At baseline and 15 minutes after each adjustment of the cisatracurium dose.

Countries

China

Contacts

Primary ContactLihong Xu
220223899@seu.edu.cn+86 18551696812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026