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

Not Applicable

Recruiting

• Conditions: ARDS; Lung Protective Ventilation
• Interventions: Drug: cisatracurium

• Registration Number: NCT06514209
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate-Severe ARDS patients	cisatracurium	The dose of cisatracurium was gradually adjusted to achieve different depth of muscle relaxation

Primary Outcome Measures

Name	Time	Method
transpulmonary pressure (PL)	At baseline and 15 minutes after each adjustment of the cisatracurium dose.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongda Hospital, Affiliated to Southeast University; 🇨🇳 Nanjing, Jiangsu, China