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NCT Number: NCT06514209

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

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.

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Key information

Age range

18 day–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Yingzi Huang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe ARDS requiring the use of NMBAs, as assessed by clinicians (Berlin definition 2012: PaO2/FiO2 < 150 mmHg, PEEP ≥ 5).
  • Age: 18-85 years.
  • Signed informed consent.

Exclusion criteria

  • History of allergy to NMBAs.
  • Open chest or abdominal injuries.
  • Patients with pulmonary masses, lung transplantation, or lung resection.
  • Contraindications to esophageal catheter placement.
  • Pregnant patients.
  • Contraindications to TOF measurement (e.g., history of neuromuscular disease, presence of a cardiac pacemaker).
  • Severe dysfunction of other organs with an expected short-term mortality (within 7 days) or palliative care.
  • Previous inclusion in this study.

Treatment and study plan

Cisatracurium

Drug

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&#39;s spontaneous breathing completely disappears, the infusion dose of cisatracurium will no longer be increased, and the titration will end.

Primary outcomes

  1. transpulmonary pressure (PL)

    Time frame: At baseline and 15 minutes after each adjustment of the cisatracurium dose.

Secondary outcomes

  1. esophageal pressure swing(∆Pes)

    Time frame: At baseline and 15 minutes after each adjustment of the cisatracurium dose.

  2. train train of four count (TOF-count)

    Time frame: At baseline and 15 minutes after each adjustment of the cisatracurium dose.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Acronym: ARDS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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