Clinical trial NCT02546947: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery
Official title: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Respiratory Distress Syndrome, Adult
Neuromuscular Blocking Agents
Atracurium
Mechanical ventilation
ARDS
partial pressure of oxygen(PaO2) /inspired oxygen (FiO2) < 200
Positive End Expiratory Pressure (PEEP) > 5 since less than 48 hrs
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.


Eligibility criteria: Inclusion Criteria:

* ARDS with a PaO2 / FiO2 \< 200 with a PEEP \> 5 since less than 48 hrs
* Informed consent

Exclusion Criteria:

* NMBA allergy
* Continuous administration of NMBA for ARDS prior inclusion
* Age \< 18 yrs

Primary outcomes:
measure: cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
References:
citation: Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stephan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.