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

NCT06514209 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • ARDS
  • Lung Protective Ventilation

Interventions

DRUG

cisatracurium

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 & Collaborators

  • Southeast University, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Days
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2025-05-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514209 on ClinicalTrials.gov