Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents Used for Acute Respiratory Distress Syndrome After Cardiothoracic Surgery

NCT ID: NCT02546947

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Appropriate clinical group

group of patients with clinical dose adjustment

Group Type: NO_INTERVENTION

No interventions assigned to this group

TOF adapted group

group with an objective of less than 2 responses to TOF stimulation monitored

Group Type: ACTIVE_COMPARATOR

Train of four monitoring

Intervention Type: OTHER

with an end point of one or two response at orbicularis oculi to TOF stimulation

Interventions

Train of four monitoring

with an end point of one or two response at orbicularis oculi to TOF stimulation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33002927 (View on PubMed)

Other Identifiers

2013-A00067-38

Identifier Type: -

Identifier Source: org_study_id