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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

History of allergy to NMBAs.

Open chest or abdominal injuries.

Patients with pulmonary masses, lung transplantation, or lung resection.

Contraindications to esophageal catheter placement.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Moderate-Severe ARDS patientsExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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