Actively Recruiting
Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome
Led by Southeast University, China · Updated on 2024-07-23
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute respiratory distress syndrome (ARDS) is a serious lung condition marked by sudden damage to the alveoli, leading to severe low oxygen levels. This research focuses on moderate to severe ARDS patients who require neuromuscular blocking agents (NMBAs) to help improve breathing through lung-protective ventilation. The study aims to explore how different levels of muscle relaxation affect lung protection and respiratory function in these patients, addressing current uncertainties about the optimal NMBA dose. Participants will receive the drug cisatracurium, starting with an initial bolus dose followed by a continuous infusion. The dose will then be gradually increased to achieve varying depths of muscle relaxation until spontaneous breathing stops or the maximum dose is reached. This approach allows researchers to observe changes in respiratory mechanics and other physiological responses at different NMBA levels. Throughout the study, measurements such as transpulmonary pressure, esophageal pressure changes, and train-of-four counts will be taken at baseline and after each dose adjustment. These assessments help evaluate the impact of muscle relaxation depth on lung function. Participants will be closely monitored for vital signs and respiratory status during the treatment period. The study is expected to conclude by June 2025.
CONDITIONS
Brief Title
Effect of Different Depths of Neuromuscular Blockade on Respiratory Mechanics in Patients With Moderate-severe Acute Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate to severe ARDS requiring neuromuscular blocking agents, defined by PaO2/FiO2 < 150 mmHg and PEEP ≥ 5
- Age between 18 and 85 years
- Signed informed consent obtained
You will not qualify if you...
- History of allergy to neuromuscular blocking agents
- Open chest or abdominal injuries
- Presence of pulmonary masses, lung transplantation, or lung resection
- Contraindications to esophageal catheter placement
- Pregnancy
- Contraindications to train-of-four measurement, including neuromuscular disease or cardiac pacemaker
- Severe dysfunction of other organs with expected death within 7 days or under palliative care
- Previous participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of neuromuscular blockade administration as determined by clinical care
Participants receive continuous infusion of cisatracurium with dose adjustments to achieve different depths of muscle relaxation. Vital signs and respiratory mechanics are monitored after each dose adjustment.
Repeated assessments after each dose adjustment
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
L
Lihong Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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